PURPOSE:

Samfilcon A multifocal toric contact lenses (CLs; ULTRA® Multifocal for Astigmatism, or UMFfA) are monthly planned replacement silicone hydrogel CLs. The unique polyvinylpyrrolidone-containing silicone hydrogel material is designed to retain moisture and support the tear film. This study aimed to assess satisfaction of existing CL wearers, and their eyecare professionals (ECPs), following a trial of UMFfA CLs.

METHODS:

Between April 2021 and January 2022, 2,914 adult patients (average age 51 years) were fitted with UMFfA by 565 ECPs from 11 European countries. Questionnaires recorded patient satisfaction based on overall comfort (throughout the day, at the end of the day, after extended screen use), vision (distance, intermediate, and near), ease of transition between distances, and handling. Eligible patients included new CL wearers (either without prior vision correction or currently wearing spectacles as vision correction), or existing CL wearers.

RESULTS:

About half of participants (52%, n=1,519) were existing CL wearers; 87% began CL wear >4 years prior to the study. 78% of existing CL wearers agreed that UMFfA CLs provided sharp, clear near, intermediate and distance vision, with easy transition between distances, and 76% agreed that these lenses were superior to their previous CL. About 90% of patients were satisfied with overall comfort throughout and at the end of the day, and 75% were satisfied with comfort during extended screen use. Furthermore, 85% of patients stated they would continue to wear UMFfA CLs beyond their trial. After fitting 2,914 patients in total, 90% of ECPs were very satisfied (20%) or satisfied (69%) with UMFfA, 91% were very likely (42%) or likely (48%) to consider these CLs as the first option for patients who needed a multifocal toric vision correction option, and 90% would recommend them to a colleague.

CONCLUSION:

Patients and ECPs were highly satisfied with UMFfA. Over three-quarters of patients would elect to continue with wear and preferred UMFfA to their previous CLs.

PURPOSE:

The Zenlens custom scleral lens (SL) incorporates design flexibility and extensive customizable parameters to enable a precise, custom fit in individuals with a range of ocular conditions and corneal irregularities. Among the available customizations, MicroVault technology allows the lens to precisely vault over a peripheral obstruction. This retrospective multi-country case review aimed to gain insight into real-world visual outcomes and lens fitting practices with Zenlens. This sub-analysis focused on customization with MicroVault.

METHODS:

Ten eye care practitioners (ECPs) from three countries provided a deidentified retrospective convenience sample of ≥5 cases each using a standardized case report form (CRF), including ≥3 complex cases with a range of customizations. Data collected included best-corrected visual acuity (BCVA), comfortable wearing time, lens fitting patterns, and number of modifications required to achieve a successful fit. The protocol received central institutional review board exemption. Descriptive statistics are reported.

RESULTS:

The full analysis set included all submitted CRFs from 10 ECPs (62 eyes; 45 patients). This sub-analysis included CRFs from 7 ECPs utilizing MicroVault technology: 10 patients (7 female, 3 male; mean±SE age 50±5 years) and 11 eyes (OD, 5 patients; OS, 4 patients; OU, 1 patient). The most common diagnosis was keratoconus (5/11 eyes); other reasons for SL utilization included high or irregular astigmatism. Reasons for MicroVault utilization included ocular trauma and scarring, and a post-surgical bleb. Results are reported for all eyes/patients, unless otherwise stated. Prior to SL fit, a best-spectacle-corrected visual acuity of 20/25 or better was achieved in 18% of eyes. Mean±SE number of modifications required to achieve the final fit was 2±0. The resulting MicroVault elevations had a mean±SE (IQR) diameter of 3±0 (1) mm and depth of 263±45 (80) µm (data missing for 1 eye). A BCVA of 20/25 or better, and 20/32 or better, was achieved in 64% and 91% of cases, respectively, with a mean±SE comfortable wearing time of 14±1 hours.

CONCLUSION:

This sub-analysis provided valuable insights into fitting practices and visual outcomes with Zenlens utilizing Microvault technology, demonstrating its utility in enabling a precise fit in eyes with peripheral elevations that may impede lens fit or comfort.

PURPOSE:

When patients with complex corneal conditions also require presbyopic correction, custom scleral lens (SL) options become increasingly important. Zenlens (an SL) incorporates design flexibility and extensive customization capabilities to help eye care practitioners (ECPs) achieve a precise fit in patients. This SL also provides the opportunity for multifocal optics, achieved using decentered optics that align the near zone over the visual axis (slightly nasal and superior for each eye) to help provide clear vision. Documented real-world evidence with Zenlens is limited; therefore, a retrospective multi-country case review was performed to gain insight into real-world visual outcomes and lens-fitting practices. This sub-analysis focused on multifocal lenses.

METHODS:

Ten ECPs from three countries provided a deidentified retrospective convenience sample of ≥5 cases each using a standardized case report form (CRF), including ≥3 complex cases with a range of customizations. Data collected included lens fitting patterns, best-corrected visual acuity (BCVA), comfortable wearing time, and number of modifications required to achieve a successful fit. The protocol received central IRB exemption. Descriptive statistics are reported.

RESULTS:

The full analysis set included CRFs from 10 ECPs (62 eyes; 45 patients). This sub-analysis included CRFs from four ECPs utilizing Zenlens with multifocal optics and included five patients (three female, two male); nine eyes (OU in four patients; OD in one patient). The most common diagnosis was keratoconus (three patients; five eyes). Reasons for using the lenses included unsatisfactory outcomes with other lenses, including poor visual outcomes and a lack of customization options. Results are reported for all patients/eyes. Mean±SE add power, near zone diameter, and pupil diameter were 1.78±0.25 D, 2±0 mm, and 3±0 mm, respectively. A BCVA at distance of 20/25 or better, and 20/32 or better, was achieved in 67% and 100% of cases, respectively. Corrected near visual acuity of 20/20 or better, and 20/32 or better, was achieved in 67% and 89% of cases, respectively. Mean±SE comfortable wearing time was 12±1 hours. Mean±SE number of modifications required to achieve the final fit was 2±0. No adverse events were reported.

CONCLUSION:

This sub-analysis provided valuable insights into real-world visual outcomes and lens fitting practices with Zenlens using multifocal optics.

BACKGROUND:

Scleral lenses (SLs) can benefit patients with a range of ocular conditions, including high or irregular astigmatism. Customization of toric peripheral curves can enable accurate landing on an asymmetrical sclera and aid in troubleshooting poor comfort, edge compression, or edge impingement.

Case Summary

We present three case studies demonstrating the use of a custom SL (Zenlens) with modifiable toric peripheral curves, among other customizable parameters, in patients with high or irregular astigmatism and comorbid corneal conditions. Case 1: patient with Salzmann nodular degeneration and irregular astigmatism (OS); best-spectacle-corrected visual acuity (BSCVA), 20/80; keratometry, 42.5D@135 / 46.5D@025; baseline refractive error, +2.00−5.00×084. Best-corrected visual acuity (BCVA) improved to 20/20 with an SL customized using toric peripheral curves (Steep 1 / Steep 5) to accommodate scleral irregularities. Case 2: patient with irregular astigmatism and peripheral corneal and scleral scarring from a ruptured globe repair (OS); BSCVA, 20/40; keratometry, Flat 42.8D / Steep 44.5D; baseline refractive error, −3.50+2.00×180. BCVA improved to 20/20 with an SL customized with peripheral elevation to accommodate the scar and toric peripheral curves (Flat 2 / Steep 1) to accommodate scleral irregularities. Case 3: existing SL user with high astigmatism and suspected keratoconus (OU); BCVA 20/20 (OD and OS); keratometry, 42.0D@014 / 45.5D@104 (OD) and 42.25D@158 / 47.0D@068 (OS); baseline refractive error, −2.50−3.25×014 (OD) and −3.25−3.50×158 (OS). The SL was customized with toric peripheral curves (Standard / Steep 1 [OS] and Flat 3 / Steep 5 [OD]) to accommodate scleral irregularities, two distinct sagittal depth values to accommodate limbal asymmetry, and a peripheral elevation. In all cases, final fit was achieved with 2–3 revisions, resulting in a BCVA of 20/20, good lens clearance, centration, and rotational stability, with no conjunctival impression rings or edge lift. A comfortable wearing time of 8–14 hours and high levels of satisfaction were reported.

CONCLUSION:

This case series demonstrates the utility of toric peripheral curve customization options with Zenlens as a viable vision correction option in patients with irregular astigmatism and a variety of corneal complexities and ocular comorbidities.

BACKGROUND

Recent studies have demonstrated that oxidative stress is involved in pathogenesis of dry eye disease. Raised levels of reactive oxygen species, lipid oxidative stress markers, and inflammatory cells were found in the conjunctiva and tear film of patients with Sj”gren syndrome and dry eye animal and cell models. For most patients with mild dry eye symptoms, over-the-counter dry eye drops (OTC-DED) are the first line of therapy. OTC-DED can help maintain ocular surface homeostasis by reducing oxidative stress. The purpose of this in vitro study was to examine the antioxidant effects of a novel OTC-DED, Blink Nourish (BN), and two other common OTC-DEDs on human corneal epithelial cells (HCECs).

METHOD

Riken-HCECs were pre-exposed to the OTC-DED for 30 minutes and then exposed to CellROX Green (CRG) Reagent for 30 minutes. CRG media were removed, and the cells were then exposed to 0.003% or 0.006% hydrogen peroxide (H2O2) and OTC-DED. Changes in oxidized CRG relative fluorescent units were measured every 15 minutes for 2 hours. Integrated responses of the change in relative fluorescent units were analyzed by calculating the areas under the curve (AUC) for each test well over the time course. Upon completion of the antioxidant experimental time course, cells were assessed for cellular metabolic activity using alamarBlue.

RESULTS

No significant differences were observed with cells exposed to 0.003% H2O2; however, cells exposed to 0.006% H2O2 had significantly lower metabolic activity versus the Hanks' Balanced Salt Solution control. Cells exposed to 0.003% H2O2 and 0.006% H2O2 had increased CRG fluorescence and AUC of fluorescence over time. BN and both BN and Refresh Relieva had significantly lower AUCs versus the cells exposed to

0.003% and 0.006% H2O2 controls, respectively. Systane Hydration and Biotrue Hydration Boost both had significantly higher AUCs versus the 0.003% H2O2 control.

CONCLUSION

These results indicate the antioxidant effects of BN with HCECs compared with common OTC-DED products in this in vitro cell model. The BN formulation exhibits antioxidant activity and demonstrates potential to maintain homeostasis of the ocular surface environment.

BACKGROUND:

A custom scleral lens (SL), Zenlens, utilizes integrated design flexibility and customization options to achieve a precise fit in patients with various corneal conditions; Zenlens ECHO provides additional customization for advanced degenerative, postoperative, or traumatic corneal conditions. Although successful lens fitting can be achieved with standard clinical technology, use of optical coherence tomography (OCT) and scleral profilometry helps streamline the process. Case Summary A 72-year-old male with a history of corneal transplant attended our clinic for SL fitting (OS); he had previously discontinued SL use due to ocular discomfort. He presented with a tilted cornea post-graft; profilometry revealed considerable elevation of a superior graft with significant elevation change in that meridian. Pre-SL fitting visual acuity (VA) and keratometry were 20/400 and 62.1/72.7@058, respectively. The deepest diagnostic lens was used during fitting but still maintained contact with the graft. The first lens ordered utilized Bi-Elevation to vault over the graft (lens parameters: 7.30mm base curve (BC), 17.0mm diameter oblate, plano power, sagittal depth (SD): 6200/6700µm, standard advanced peripheral system). Additional modifications were required to prevent contact with the graft without overvaulting the other quadrants, as the SL still impacted on the superior graft. Optimal SL fit was achieved during the fourth fit using Zenlens ECHO. The BC was flattened to increase midperipheral clearance, and the SD of each quadrant (Q) was adjusted independently. Final lens parameters were 7.77mm BC, 17.0mm diameter oblate, +5.75 power, SD: Q1 6.400 Flat 1, Q2 5.900 Steep 1, Q3 6.800 standard, Q4 6.000 standard. OCT demonstrated acceptable alignment with the superior graft; a very light touch with no staining was observed after 6 hours of wear (considered acceptable provided the graft continues to remain healthy). At the 8-week follow-up, the patient’s VA was 20/20 and he could comfortably wear the lens all day. The patient was advised to return for a routine SL appointment in 6 months.

CONCLUSION:

This case study provides real-world insights into Zenlens outcomes and fitting practices using clinical technology in a patient with a postoperative corneal abnormality, demonstrating the prolonged comfortable wearing time and improved vision that can be achieved by utilizing Zenlens ECHO.

BACKGROUND: Perfluorohexyloctane ophthalmic solution (PFHO) is indicated for the treatment of signs and symptoms of dry eye disease (DED). In randomized controlled trials, significant reductions in signs and symptoms of DED were observed beginning at day 15 (the first postbaseline assessment) for PFHO compared with a hypotonic saline control. This prospective, multicenter, open-label, phase 4 study evaluated patient perceptions and satisfaction during the first 14 days of treatment with PFHO.

METHOD: This study enrolled adults with a history of DED for =6 months and clinical signs of Meibomian gland dysfunction. PFHO was instilled in both eyes QID for 14 days. Patients completed early outcome surveys during 4 clinic visits: day 1 (pretreatment [baseline]; 5 and 60 minutes post-PFHO instillation) and days 3, 7, and 14. DED symptom severity (overall and each of 8 individual symptoms) and treatment satisfaction were rated on a visual analog scale (range, 0-100). The Ocular Surface Disease Index (OSDI) was completed at baseline and day 14.

RESULTS: Ninety-nine patients were enrolled (mean age, 61.3 years; 85.9% females). Mean (SD) VAS score for overall DED symptom severity was 72.1 (17.0) at baseline and decreased to 38.5 (22.8) at 5 minutes post-instillation, 31.7 (22.1) at 60 minutes post-instillation, 33.2 (25.1) at day 3, 27.8 (22.3) at day 7 (primary endpoint), and 24.7 (23.0) at day 14. Reduction in overall symptom severity was statistically significant at all postbaseline timepoints, including the day 7 primary endpoint (mean change from baseline: -44.5 [61.7% reduction]; P<0.0001). significant reductions in severity were also observed for all 8 symptoms eye dryness burning stinging eye itching light sensitivity eye pain eye tiredness eye irritation and blurred vision at all postbaseline assessments p><0.0001). mean sd osdi total score decreased from 50.5 16.7 at baseline to 18.4 13.9 at day 14 mean change from baseline: -32.1 p><0.0001). median ratings of treatment satisfaction were 83.0 at day 3 86.0 at day 7 and 90.0 at day 14.>

CONCLUSION: Early in the course of treatment with PFHO, patients with DED experienced significant reductions in dry eye symptom severity. Treatment satisfaction with PFHO was high.

BACKGROUND:

Zenlens, a custom scleral lens (SL), utilizes integrated design flexibility and customization options to achieve a precise fit in patients with a variety of corneal conditions. Customization options include Bi-Elevation and MicroVault technology: Bi-Elevation involves creating two sagittal depth values inside the vaulting chamber to enable accurate and uniform landing on an asymmetrical sclera, and MicroVault technology allows the lens to precisely vault over a peripheral obstruction.

Case Summary

We report the case of a 35-year-old white female with keratoconus in both eyes, with no other ocular comorbidities, who had undergone corneal crosslinking 2 months before SL fitting. At baseline, best-spectacle-corrected visual acuity was 20/50 (OD) and 20/70 (OS); keratometry readings were 50.8×58.6 (OD) and 44.5×52.9 (OS); refractive error was +0.50–6.00 × 084 (OD) and –1.00–4.00 × 089 (OS). Optimal fit was achieved within three revisions. Final lens parameters were 16-mm diameter prolate lenses; horizontal visible iris diameter 11.8 mm (OD) and 11.9 mm (OS); base curve 6.81 mm (OD) and 7.6 mm (OS); lens power –7.00–1.50 × 120 (OD) and –2.25–1.00 × 150 (OS). Toric peripheral curves were added to both final lenses (Steep 6/Steep 4 [OD] and Steep 4/Steep 7 [OS]). Bi-Elevation was added to the lenses for both eyes and optimized within 2–3 revisions, to eliminate residual lens movement and improve lens position/centering. Final sagittal depths were 4650/4800 µm (OD) and 4400/4600 µm (OS). After finalizing lens movement and position, to accommodate a pinguecula, a single MicroVault was fitted (OD) in the final revision: decentration 8 mm; axis 325; diameter 2.5 mm and depth 250 µm. Adequate lens clearance and centration were demonstrated, with no lens impingement, minimal conjunctival impression rings, and no edge lift. At Week 4, best-corrected visual acuity was 20/20, with a comfortable wearing time of 16 hours. No ocular symptoms were reported. The patient was advised to return for a routine follow-up in 6 months to assess corneal stability.

CONCLUSION:

This case report provides real-world evidence of Zenlens outcomes for a patient with keratoconus. This custom SL improved vision with full day comfortable wearing time and no ocular symptoms.

BACKGROUND: Dry eye is a disorder of the ocular surface due to tear deficiency, excessive tear evaporation, or irregular composition of tears. For most patients with mild dry eye symptoms, over-the-counter (OTC) dry eye drops are the first line of therapy. Blink Nourish (BN) is a novel, preservative-free lubricating eye drop containing glycerin, sodium hyaluronate, electrolytes, vitamin B12, and stabilized vitamin C, along with three amino acids and trehalose. In this study, BN was evaluated against other top-selling OTC lubricating eye drops to understand the biological effects on human corneal epithelial cells (HCECs).

METHOD: Transformed HCECs were maintained in EpiLife medium supplemented with human corneal growth supplement at 37°C, 5% CO2, and 95% relative humidity. HCECs were then exposed to 75% EpiLife medium with either 25% Hanks' Balanced Salt Solution (HBSS) as a control or 25% of each of five OTC dry eye products (including BN) for 24 hours, with each test formulation adjusted with NaCl to 400 or 450 mOsm/kg. Upon completion, the cell culture supernatants were collected and analyzed for release of cytokines interleukin (IL)-6 and tumor necrosis factor-α and chemokine IL-8, and cell metabolic activity was determined by the alamarBlue assay.

RESULTS: Metabolic activity was significantly higher than HBSS control with BN (p<0.05) at both 400 and 450 mosm kg. in contrast metabolic activity was significantly lower than control for three of the four comparator drops and no significant difference for the fourth comparator. furthermore bn was associated with significantly lower mean cytokine responses versus the hbss control. all comparator eye drops were associated with significant increases in il-6 at both 400 and 450 mosm kg. in the il-8 assessment hbss control was associated with a large increase at 450 mosm kg which was not seen with bn and one of the four comparator drops.>

CONCLUSION: These results demonstrate the osmoprotective effects of BN in vitro. The combination of added nutrients and amino acids within the novel BN formulation has the potential to contribute to maintaining homeostasis of the ocular surface environment and improve symptoms of dry eye.

BACKGROUND: Brimonidine tartrate ophthalmic solution 0.025% (BTOS) is indicated for the relief of redness of the eye due to minor eye irritations. Although BTOS is available over-the-counter (OTC) in the US, physicians may choose to prescribe the product. This study sought to understand more about BTOS prescriptions by reviewing medical and pharmacy claims databases.

METHOD: The IQVIA Longitudinal Prescription Claims (LRx), Medical Claims (Dx), and Market Access Library data were used to analyze the demographics, baseline clinical characteristics, treatment patterns, and treatment costs of patients using BTOS.

RESULTS: For the full year periods 2020–2023, data were available for 8,611 patients. The majority of patients were aged 18–74 years and included more females (58%) than males (42%). Insurance/payer types were 51.8% cash, 41.1% commercial with the remainder Medicaid, Medicare or unknown. While most prescriptions were from ophthalmologists (54.6%) and optometrists (39.5%), a broad range of health professionals including family medicine doctors, nurse practitioners, anesthetists/nurse anesthetists, and physician assistants also prescribed BTOS. Ophthalmic conditions recorded in ≥30% of patients included 'disorders of eyelid, lacrimal system and orbit' (44.1%), 'disorder of lens' (40.3%), 'disorders of conjunctiva' (36.5%), 'glaucoma' (35.9%), and 'disorders of ocular muscles, binocular movement, accommodation and refraction' (33.2%). 38.7% of patients were also taking ophthalmic corticosteroids, and 35.2% artificial tears; additional concomitant medications included anti-allergy medications, anti-infectives and anti-inflammatories. Analysis of reporting intervals demonstrates an average of 1.97 claims per patient, with an average of 74 days between fills. Time on therapy (time between index claim and date of last claim plus days of supply of last claim agent) averaged 51 days. A small proportion of patients (7%) remain on therapy for over 271 days.

CONCLUSION: A wide range of healthcare professionals choose to prescribe BTOS to their patients, with comorbidities and concomitant medications suggesting that ocular redness is often a secondary complaint. For the majority of patients, BTOS use is short term; however, the data presented here are likely to underestimate actual use as they do not capture the potential switch to OTC BTOS by patients.

PURPOSE:

Contact lens (CL) wearers continue to seek greater comfort and performance throughout their CL-wearing experience, and typically wear their CLs for substantial portions of the day. Biotrue Hydration Plus is a unique multi-purpose solution (MPS) developed to improve comfort among CL wearers, and formulated with the moisturizer hyaluronan, surfactants poloxamine 1107 and poloxamer 181, an electrolyte (potassium), and an osmoprotectant/antioxidant (erythritol). This real-world in-home use test assessed the performance of this MPS among users who self-reported typically wearing CLs for ≥10 hours per day (excessive CL wearers).

METHODS:

CL wearers were recruited online through consumer panel providers. Eligibility required participants to be at least 18 years old, be regular users of soft CLs, and to have completed an eye exam within the past 2 years. Enrolled participants were instructed to use the study MPS with a new pair of CLs for 7 days. They subsequently completed an online survey on a 7-point Likert scale to assess the product’s performance. A two-sided exact binomial test assessed whether agreement was indicated for more than 50% of responses for performance attributes.

RESULTS:

A total of 344 participants who met the criteria for excessive CL wear participated in this study. This population was 53.2% female with a mean (SD) age of 42.7 (12.0) years. Before the trial period, 66.3% reported CL dryness, 61.0% tired eyes, 42.7% eye strain, and 41.8% blurry/fluctuating vision. At the end of the trial period, 98.5% reported satisfaction with the new MPS. In addition, 96.2% agreed that the MPS “is gentle on my eyes”, 95.9% “keeps lenses feeling clean”, 92.2% “helps keep my contacts comfortable so I do not feel like my eyes are tired”, 93.9% “helps my lenses stay comfortable throughout the day”, 92.2% “helps prevent CL dryness”, and 92.2% “helps my lenses stay comfortable even at the end of the day”. Agreement responses were statistically significantly greater than 50% for all performance attributes (p<0.05).>

CONCLUSION:

This new MPS contributes to a positive CL wearing experience even among CL users who wear their CLs for 10 or more hours per day.

BACKGROUND: Conjunctival hyperemia (CH) occurs through vasodilation reactions in the conjunctiva. Existing treatments, including ocular vasoconstrictors and antihistamines, provide temporary relief; however, continued use has been associated with tachyphylaxis and adverse events. This study explored healthcare professionals' (HCPs) experience treating CH and satisfaction with available treatments, including brimonidine tartrate (0.025%), an ophthalmic decongestant available over the counter (OTC) in the United States and via prescription only in Europe.

METHOD: A semi-structured interview guide was developed based on a targeted literature review. Interviews were conducted with ophthalmologists in the US (n=4), Spain (n=4), Portugal (n=4) and France (n=4) who had experience treating CH with a range of treatments, including brimonidine tartrate (0.025%). Interview topics included CH pathology, treatment decisions, unmet needs, and treatment satisfaction. Interviews were recorded, transcribed verbatim and analyzed using content analysis. This study received ethical review exemption from the WCG Institutional Review Board.

RESULTS: HCPs had 14–25 years' experience treating CH and treated 40–100 CH patients in the prior month. HCPs reported limitations with existing treatments, such as eye sensitivity and rebound redness. Brimonidine tartrate (0.025%) was reported to be fast-acting and to cause fewer adverse events. HCPs emphasized the importance of determining and treating the cause of CH but noted brimonidine tartrate (0.025%) was a well-tolerated adjunctive option. In Europe, it was suggested that while prescription-only status reduces accessibility, it helps ensure HCPs monitor the cause of CH. Conversely, US HCPs stated that while OTC availability increased accessibility, it was harder to monitor patient usage.

CONCLUSION: HCP experience of the current treatment landscape has previously been limited to treatments with short-term efficacy and adverse events. Brimonidine tartrate (0.025%) provides an effective and well-tolerated solution which addresses the aesthetic needs of patients with CH. HCPs highlight the need to identify and treat the underlying cause of CH, but report brimonidine tartrate (0.025%) can be used as an adjunctive treatment.

PURPOSE:

Advances in contact lens technologies, including among toric options for astigmatism, can generate interest among both prescription eyeglass and contact lens (CL) wearers. In general, patients look to the eye care practitioners (ECPs) to provide education and recommendations for vision care options that meet their needs. The kalifilcon A daily disposable silicone hydrogel toric CL (INFUSE/ULTRA ONE DAY for Astigmatism [IfA]) is uniquely designed to help maintain ocular surface homeostasis and also incorporates OpticAlign Design and high-definition optics for clear, stable vision. The present work assessed early patient experience from the first 100 patients to complete a real-world evaluation study of the IfA lens.

METHODS:

ECPs invited eligible astigmatic patients to trial IfA lenses for a period of 5 days. Participants were fitted for the IfA lens, completed the 5-day trial period, and completed an online survey to assess satisfaction, with at least 60% of participant responses subsequently validated by telephone contact. A two-sided exact binomial test assessed whether a favorable response was indicated in >50% of responses for key Likert scale attributes.

RESULTS:

Of the first 100 participants to complete the study, the majority were female (73.0%) and mean (SD) age of the population was 37.9 (12.9) years. Prior to the trial, 58.0% were existing contact lens wearers, and the remainder were eyeglass wearers. 94.0% of participants expressed agreement (agreed/strongly agreed) that it is important for ECPs to educate them on innovative technologies in eye health (p< 0.001). At the end of the trial period, 93.0% agreed/strongly agreed that the IfA lens is easy to handle (p<0.001). in addition 92.0 reported an overall opinion of the lens as good very good or excellent 89.0 were likely to continue with ifa after the trial period and 96.0 also expressed favorable likelihood of recommending the lens to a friend or family member who wears cls all p><0.001).>

CONCLUSION:

This early evaluation offers insights into patient interest in ECP education regarding innovative technologies as well as overall experience with the IfA lens, including ease of handling, overall opinion, willingness to continue wearing, and willingness to recommend the lens to others.

BACKGROUND: Lifitegrast ophthalmic solution 5% is indicated for the treatment of signs and symptoms of dry eye disease (DED). This survey of eyecare providers aimed to examine real-world utilization and outcomes of lifitegrast in the treatment of patients with DED.

METHOD: Eyecare providers (ECPs: ophthalmologists and optometrists) treating patients with DED were invited to complete a provider survey. The survey included items regarding practice characteristics, lifitegrast utilization, satisfaction, and adverse events (AEs). Satisfaction with lifitegrast relative to other prescription eye drops was rated on a scale from 0 (very dissatisfied) to 10 (very satisfied). ECPs also provided case study data for up to five patients with DED who initiated lifitegrast treatment.

RESULTS: Twelve ECPs (6 MDs, 6 ODs) responded; they reported on a mean of 1288 (range, 35-6000) patients diagnosed with DED per year, of whom 21%, on average, received lifitegrast treatment. Seven ECPs provided 33 case reports. Overall, ECPs reported that DED severity was mild in 24.1%, moderate in 50.5%, and severe in 19.1% of patients to whom lifitegrast was prescribed. Two-thirds (67%) of ECPs reported near/complete symptom resolution in patients after 1 to 3 months of lifitegrast treatment. Satisfaction ratings (mean [range]) for onset and effectiveness were 6.8 (3-9) and 6.6 (3-9), respectively. Satisfaction ratings for reduction of DED signs were: increased tear film break-up time, 5.8 (3-9); reduced conjunctival/corneal staining, 6.9 (3-9); increased Schirmer test score, 6.0 (3-9); and increased tear meniscus height, 6.0 (3-9). Symptom reduction satisfaction ratings were: itching, 5.3 (1-9); dryness, 6.9 (3-9); burning, 6.3 (1-9); redness, 6.2 (4-9); pain, 6.3 (3-9); light sensitivity, 6.5 (3-9); blurred vision, 6.8 (4-9); and reduced OSDI severity, 7.0 (3-10). Improvement was sustained during treatment up to 12 months, supported by case data (mean [range], 15 [1-69] months). AEs considered by the ECPs as related to lifitegrast use included blurred vision, burning/stinging, and dysgeusia; all AEs were mild or moderate in severity.

CONCLUSION: Findings from this real-world survey of ECPs highlight the rapid and durable response associated with lifitegrast for the treatment of patients with DED. AEs were consistent with the known safety profile of lifitegrast.

BACKGROUND: Semifluorinated alkanes (SFAs) are amphiphilic molecules with a fluorinated carbon segment (F) and a hydrocarbon segment (H) of differing chain lengths. This in vitro study evaluated the impact of chain length on SFA evaporation rate (Revap) and inhibition of Revap of saline. SFA dry eye drops include one consisting of 100% SFA (perfluorohexyloctane; F6H8; MIEBO) and one with the SFA perfluorobutylpentane (F4H5) as a vehicle (cyclosporine ophthalmic solution 0.1%; CsA 0.1%; VEVYE).

METHODS: Evaporation rates were measured gravimetrically at 35øC in a masked study. The following SFA-containing dry eye drops and comparator SFAs were evaluated: F4H2, F4H5/CsA 0.1%, F6H7, F6H8, and F6H10. Revap of 1 mL of each SFA and saline alone or saline with an 11- or 100-æL aliquot of SFA layered over the top was evaluated in a container with an exposed surface area similar to that of the human ocular surface. Total sample weight was recorded to five decimal places every 10 minutes over 100 minutes. Revap for each sample was obtained from the slope of the best-fit line using least squares linear regression analysis.

RESULTS: Mean (SEM) Revap in mg/min were 102 (25), 6.0 (0.6), 0.58 (0.20), 0.15 (0.017), and 0.12 (0.09) for F4H2, F4H5, F6H7, F6H8, and F6H10 alone, respectively (n=3-9). Revap of saline alone was 10.53 (0.06) æm/min. Layering 100 æL F4H5/CsA 0.1% over saline had no effect on Revap (P=0.52) while F4H2, F6H7, F6H8, and F6H10 inhibited the Revap of saline by 8.4%, 16.7%, 73.9%, and 60.7%, respectively (P<0.001 for all vs saline. none of the sfas had a significant inhibitory effect on revap of saline when applying a single 11 l drop except for f6h8 p><0.0001 vs saline n="10-25).">

CONCLUSIONS: Chain length and volatility of SFAs appeared to impact their ability to inhibit Revap of saline in this in vitro model. Shorter chain length SFAs F4H2 and F4H5/CsA 0.1% had minimal or no effect on Revap while longer chain length SFAs F6H8 and F6H10 had the maximal effect. The data reinforce the suitability of F6H8 as an anti-evaporative agent for the treatment of signs and symptoms of dry eye disease.

BACKGROUND: Perfluorohexyloctane ophthalmic solution (PFHO), the first and only prescription eye drop for dry eye disease (DED) directly targeting tear evaporation, was introduced in the United States in September 2023. This claims database study describes clinical and demographic characteristics of PFHO early adopters and refill rates after initial prescriptions.

METHOD: Adult patients (=18 years) newly initiating PFHO from September 1-November 30, 2023, were identified from the IQVIA Longitudinal Prescription Claims database. Eligible patients had linkage to the IQVIA Professional Fee Claims database and a 12-month pre-initiation period ("baseline") for sample characterization. Descriptive statistics were produced for demographics, index prescription characteristics, and baseline clinical characteristics including previous medication use and DED diagnosis. Refill rates within 60 days were assessed and descriptively compared to a cohort initiating cyclosporine ophthalmic solution 0.05% (CsA, branded or generic).

RESULTS: In total, 7209 patients (79.9% female; mean age, 60.6 years) initiated PFHO and 75,871 initiated CsA (80.4% female; mean age, 66.6 years). Index prescriptions of PFHO and CsA were received primarily from optometrists (54.7% and 42.9%, respectively) and ophthalmologists (43.1% and 47.5%). Overall, only 38.5% of patients had a claim indicative of DED in the baseline period. Common codes indicated aqueous deficient (28.7%), evaporative (11.3%), or inflammatory (16.7%) DED, reflecting its multifactorial nature. Baseline DED medication use was higher among PFHO (46.6%) than CsA (8.1%) patients, suggesting potential dissatisfaction with prior therapy. A higher proportion of PFHO patients (93.1%) than CsA patients (56.9%) received an index prescription of =30 days' supply. The 60-day refill rate (among patients with =30 days' supply of their index prescription and only one claim on index date) was 70.7% for PFHO versus 43.4% for CsA.

CONCLUSION: DED appears under-recorded in the claims, as almost two-thirds of PFHO and CsA patients received the index prescription despite not having a recorded DED diagnosis. The higher refill rate for PFHO versus CsA 0.05% suggests a higher degree of patient satisfaction with this new, first-in-class treatment for DED.

BACKGROUND: Lifitegrast ophthalmic solution, 5.0% is an anti-inflammatory agent indicated for the treatment of signs and symptoms of dry eye disease. This post-hoc analysis of phase 3 pivotal data identified patients with rapid and pronounced reduction in dry eye symptoms with lifitegrast treatment and evaluated defining characteristics.

METHODS: This was an exploratory analysis of data from the OPUS-2 and OPUS-3 studies (NCT01743729, NCT02284516): 12-week, prospective, double-masked, multicenter, placebo-controlled, randomized, parallel-arm clinical trials. Pooled data in the lifitegrast treatment arm were analyzed using a cluster analysis to identify homogenous populations of patient response types based on percent change from baseline in eye dryness score (EDS; as evaluated on a VAS 0-100 scale) at Days 14, 42, and 84. Patients with Sjogren's syndrome or incomplete data were excluded from the analysis. Patient demographics and baseline characteristics among the defined subgroups were evaluated.

RESULTS: The OPUS 2/3 analysis set included 1292 participants. The following 5 patient subgroups were identified in the lifitegrast treatment arm: early sustained responders with =60% reduction in EDS at all timepoints (n=113; 17.7%); steady responders with =20%, =40%, and =60% reduction in EDS at Days 14, 42, and 85 (n=113; 17.7%); Day 84 response of =60% (n=127; 19.9%); Day 84 response of =30% to <60% n="119;" 18.7 day 84 response of><30% n="166;" 26.0. there were significant differences in mean symptom scores across the 5 patient subgroups p><0.001), with numerically lower mean symptom scores for eye pain burning stinging foreign body sensation and photophobia in the patients demonstrating an early sustained response.>

CONCLUSION: The majority of patients treated with lifitegrast achieved =30% reduction in EDS by Day 84, with over half reaching a =60% reduction at this time point. The patient group with rapid and sustained EDS reductions by 2 weeks of treatment tended to have lower symptom scores than the other subgroups, suggesting that early treatment may be beneficial for maximal response. Further studies to corroborate these findings are warranted.