PURPOSE:

When fitting orthokeratology (Ortho-K) lenses, corneal sagittal height differential (SHD) along the principal meridians where the landing zone is located is an important consideration. For patients with SHD ≥30μm, toric peripheral curves aid in achieving a successful fit. The Arise Ortho-K (oprifocon A) lens is indicated for overnight wear for the temporary reduction of myopic refractive error up to −5.00D and astigmatism up to 1.50D. This study aimed to evaluate the safety and effectiveness of the Arise Ortho-K lens with toric posterior peripheral curves. This analysis outlines the lens fit and stability results.

METHODS:

This single-treatment, multicenter, open-label study enrolled Ortho-K lens-naïve patients aged ≥12 years with spherical refractive error between plano and −5.00D, astigmatism ≤1.50D, and a corneal topography SHD between the principal meridians of ≥30μm at an 8mm chord diameter. Patients were required to wear the lenses for ≥8 hours overnight for 3 months, and attended follow-up visits at Day 1, Week 1, and Months 1, 2, and 3. Lens fit (centration and movement) was assessed at the Dispensing and Day 1 visits. Stability measures included the proportion of eyes achieving refractive stability, eyes achieving stable keratometry readings, and eyes achieving stable uncorrected distance visual acuity (UDVA).

RESULTS:

Of 76 patients (152 eyes) dispensed Arise Ortho-K lenses, 46 (92 eyes) completed the study. The majority of discontinuations occurred by Week 1, with the most common reason for discontinuation being voluntary withdrawal. Monocular high-contrast UDVA of 20/40 or better in both eyes was achieved by 93% (42/45) of patients at the Month 3 follow-up visit. Acceptable lens fit was reported for 96% of eyes and patients at the Dispensing Visit. Following the first night of overnight wear, acceptable lens fit assessments were reported for 96% of eyes and 94% of patients. There were no reports of poor lens fit assessments. At every follow-up visit, ≥80% of patients achieved adequate corneal centration in both eyes; adequate centration remained consistent throughout visits. Lens movement was adequate for 94% of eyes and 93% of patients at the Dispensing Visit and for 87% of eyes and 85% of patients at the Day 1 follow-up visit. At either of two consecutive visits (Month 1 and Month 2, or Month 2 and Month 3), the proportion of eyes achieving refractive, keratometry, and UDVA stability was 84%, 87%, and 82%, respectively.

CONCLUSION:

In this study, the Arise Ortho-K lens with toric peripheral curves provided acceptable fit and adequate centration in almost all patients from the first night of overnight wear, and refractive, keratometry, and UDVA stability were achieved in a high proportion of patients. This work further supports that Ortho-K lenses with toric peripheral curves offer a valuable and effective option for patients with corneal toricity.

PURPOSE: In randomized controlled trials, perfluorohexyloctane ophthalmic solution (PFHO) was superior to a hypotonic saline control for reducing signs and symptoms of dry eye disease (DED) at the first evaluation time point (Day 15) and the primary endpoint (Day 57). The aim of this study was to evaluate early treatment effects of PFHO.

METHODS: In this prospective, multicenter, open-label, phase 4 study (NCT06309953), adults with DED instilled PFHO in both eyes QID for 14 days and completed outcome surveys during 4 clinic visits (Day 1 [pretreatment; 5 and 60 min post-PFHO instillation] and Days 3, 7, and 14). The surveys evaluated symptom severity for overall dry eye symptoms and for 8 individual symptoms using a visual analog scale (range, 0-100). Treatment response was defined as score reduction ≥30% from pretreatment baseline.

RESULTS: In 99 enrolled patients (female, 85.9%; age range, 35-81 years), responder rates for overall dry eye symptoms were 68.7% at 5 minutes post-instillation, 76.5% at 60 minutes post-instillation, 73.7% at Day 3, 85.7% at Day 7, and 83.7% at Day 14. High responder rates were also observed at all timepoints for all individual symptoms evaluated including Day 7 responder rates of 85.7% for eye dryness, 81.6% for eye irritation, 78.6% for burning/stinging, 75.5% for light sensitivity, 75.5% for eye pain, 74.5% for eye tiredness, 71.4% for eye itching, and 68.4% for blurred vision.

CONCLUSION: In patients with DED, clinically meaningful improvements in symptoms were observed in a high percentage of patients starting as early as 5 minutes post-instillation and continuing during the first 2 weeks of PFHO treatment.

PURPOSE: Dry eye disease (DED) is common in patients undergoing cataract surgery and can be further exacerbated in the postoperative period. Perfluorohexyloctane ophthalmic solution (PFHO) forms a protective layer on the tear film surface to decrease tear evaporation and is approved for treatment of signs and symptoms of DED. The aim of this study was to evaluate the effects of treatment with PFHO in patients with DED before and after cataract surgery.

METHODS: This prospective, multicenter, open-label, phase 4 study (NCT06346340) enrolled patients with DED who were candidates for phacoemulsification with posterior chamber intraocular lens (IOL) implantation. Patients instilled PFHO in both eyes QID for 30 days preoperatively and received a second 30-day PFHO treatment beginning approximately 1 month after surgery. Total corneal fluorescein staining (CFS, rated on a 0-15 scale), eye dryness (rated on a 100-mm visual analog scale [VAS]), Ocular Surface Disease Index (OSDI), and visual acuity were assessed before and after each PFHO treatment period. The 30-day postoperative standard-of-care visit also included assessment of refractive outcome (manifest refraction).

RESULTS: The study enrolled 97 patients (75.3% female; mean age, 68.6 years). Mean (SD) total CFS score improved from 5.0 (2.7) to 2.1 (2.2) and 1.3 (1.8) after the first and second 30-day PFHO treatments, respectively (P<0.001 for both. reductions from baseline in eye dryness vas score from 62.3 19.0 to 37.5 23.1 and 25.9 23.3 were observed after the first and second pfho treatment respectively while osdi score improved from 51.9 16.9 to 30.1 17.6 and 11.9 10.9 p><0.001 for all. the mean difference between absolute deviations in predicted refractive error measured before and after the presurgery pfho treatment was -0.027. at the end of the study best corrected visual acuity snellen was 20 20 or better in 91.8 of patients. two adverse events were considered related to treatment eye pruritus and noninfective conjunctivitis both were rated as mild in severity.>

CONCLUSION: In this study, presurgical PFHO treatment resulted in statistically significant reductions in signs and symptoms of DED with continued improvements in the postoperative period, demonstrating the utility of this agent in patients with DED undergoing cataract surgery.

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 baseline symptom scores across the 5 patient subgroups p><0.001), with numerically lower mean scores for eye pain burning stinging foreign body sensation itching and photophobia in the patients demonstrating an early sustained response. the early sustained responders also had robust reductions in the other symptoms at day 14.>

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. Notably, patients who exhibited rapid and sustained EDS reductions by Day 14 tended to have lower baseline symptom scores, suggesting that initiating treatment early may enhance the likelihood of achieving optimal therapeutic outcomes. Further studies are needed to corroborate these findings.

PURPOSE: Dry eye (DE) remains a persistent challenge despite widespread use of over-the-counter (OTC) lubricating eye drops. Blink Boost, Blink Nourish, and Blink Triple Care are distinct formulations designed to deliver immediate and sustained symptom relief through targeted hydration and ocular surface support. This analysis pools baseline data from three real-world, in-home use studies to explore the characteristics, treatment patterns, and unmet needs of habitual OTC drop users. By understanding patient usage behaviors and perceived gaps in efficacy, this study aims to inform more personalized approaches to DE management.

METHODS: This was a prospective cross-sectional survey study of self-identified dry eye sufferers. Adult DE sufferers in the US were recruited online from a nationally representative consumer panel. Eligible participants had used over-the-counter artificial tears/lubricants in the prior 6 months, with confirmed DE symptoms documented by ocular surface disease index (OSDI) scores at screening. Prescription eye drop users were excluded, along with participants who had undergone ocular surgery within 6 months or were allergic to any formulation of eye drops. Enrolled participants received a masked bottle (unbranded) of drops with instructions to administer a drop(s) in the morning. Participants then completed questionnaires assessing product performance at four timepoints: immediately, then 4, 8, and 10 hours after instillation. The survey instrument measured patient reported outcomes including global symptoms, a set of DE-specific symptoms and satisfaction.

RESULTS: A total of 1,865 adult participants were enrolled across all three studies (N=622 for Blink Boost and Blink Nourish, N=621 for Blink Triple Care). OSDI scores indicated a range of DE symptom severity: about one third each of participants in the overall population had mild, moderate or moderate/severe DE, respectively. Nearly half of participants (46%) had been using OTC drops for 1–5 years, and 24% for over a decade; 35% used their drops "several times a week", and 44% used them at least once per day. 74% of participants stated that they anticipated continued use of their drops for the next 6 months; of those indicated a likelihood of stopping drop use, the main reasons given were lack of need (37%) followed by lack of efficacy (21%), suggesting a significant proportion of patients are not experiencing adequate symptom relief with their habitual eye drops.

CONCLUSION: These real-world findings highlight the impact of dry eye and habitual dry eye drop use. This population was highly resistant to stopping OTC drops, with lack of efficacy a key reason, suggesting the need for tailored symptom management by matching the eye drop characteristics to each patient for optimal outcomes.

PURPOSE: Ocular lubricants are a foundational element in the symptomatic management of dry eye disease (DE). Blink Triple Care (BTC) is a benzalkonium chloride-free, over-the-counter eye drop that features a tri-action mechanism of relief, combining hyaluronic acid for hydration, nano-emulsion lipids for tear film stabilization, and osmoprotectants for cellular protection. This comprehensive formulation is designed to address both evaporative and aqueous-deficient subtypes of DE by enhancing tear film integrity, locking in moisture, and reducing tear evaporation. This study aimed to evaluate real-world patient-reported outcomes and satisfaction following short-term use of BTC in habitual artificial tear users.

METHODS: This was a prospective cross-sectional survey study of self-identified dry eye sufferers. Adult DE sufferers in the US were recruited from a nationally representative consumer panel. Eligible participants had used over-the-counter artificial tears/lubricants in the prior 6 months, with confirmed DE symptoms documented by ocular surface disease index (OSDI) scores at screening. Participants who had undergone ocular surgery within 6 months or were allergic to any formulation of eye drops were excluded. Enrolled participants received an unbranded bottle of BTC with instructions to administer a drop(s) in the morning. Participants then completed questionnaires at four timepoints: immediately, then 4, 8, and 10 hours after instillation. The survey measured patient reported outcomes including global symptoms, a set of DE-specific symptoms and treatment satisfaction.

RESULTS: A total of 621 participants screened were assigned to use BTC (56% female; 73% aged 25–64 and 25% ≥65). OSDI scores indicated mild, moderate or moderate/severe DE in 32.9%, 34.6% and 32.5% of participants, respectively. Participants reported immediate feelings of comfort and relief after using BTC (agree/strongly agree: Comfortable 87%, Hydrating 86%, Soothing 81%, Relieving 81%), and these agreement rates were consistent at 4-, 8-, and 10-hour timepoints. When patients with available data were stratified by OSDI, mild, moderate, and moderate/severe sufferers reported similarly high levels of agreement with key performance attributes immediately after use: "my dry eyes feel better", 89%, 84%, and 85%, respectively; "my dry eye symptoms are improved", 83%, 73%, and 74%, respectively; "my dry eyes feel relieved", 87%, 75%, and 75%, respectively. These agreement rates were sustained at the 4-, 8-, and 10-hour timepoints.

CONCLUSION: These real-world findings highlight the immediate and enduring relief from DE symptoms provided by BTC drops. These improvements in hydration, moisturization, comfort, and symptom relief were achieved across OSDI-assessed severity, indicating the real-world benefit to patients with DE, regardless of symptom severity.

PURPOSE: Dry eye disease (DED) is a chronic, multifactorial disease of the ocular surface characterized by visual discomfort, disturbance, and tear film instability. DED may interfere with patients' activities of daily living, impacting quality of life and well-being. Introduced in 2023, perfluorohexyloctane (PFHO) ophthalmic solution is a prescription eye drop for DED that targets tear evaporation. We sought to characterize patient-reported satisfaction with PFHO, willingness to refill, history of over-the-counter (OTC) treatment, and concurrent assessment of refill rate.

METHODS: Adults newly initiating treatment with PFHO or another prescription DED medication (cyclosporine ophthalmic emulsion 0.05% [CsA]) were identified in the Veradigm Network EHR Database linked to claims. The index period was September 15, 2023 through December 31, 2023. The index date was the date of the first PFHO or CsA prescription, with a baseline period of 12 months prior to the index date. Patients were contacted via the FollowMyHealth Patient Engagement Platform and recruited by email to participate in a survey that included questions regarding satisfaction with their DED medication, intent to refill their current medication, and prior use of OTC eye drops. The patient selection period for the survey was from September 15, 2023, through February 28, 2025. Medication refill rates were assessed via claims.

RESULTS: Of 218 patients with DED responding to the survey, 22 (10.1%) patients initiated PFHO and 133 (61.0%) initiated CsA. In the PFHO and CsA groups, mean (SD) age was 61.0 (12.9) years versus 63.9 (11.5) years; the majority were female (86.4% vs 82.7%), white (77.3% vs 78.2%), non-Hispanic (77.3% vs 81.2%), and resided in the South (68.2% vs 39.8%). For PFHO, 82% of patients were "somewhat satisfied" or "very satisfied" with treatment versus 59% for CsA. Furthermore, 73% of PFHO patients responded favorably toward refilling their prescription vs 67% of CsA patients. The actual proportion of patients with at least one recorded refill was 82% for PFHO vs 69% for CsA. Most PFHO (77%) and CsA (86%) patients previously used OTC eye drops, with 68% and 53%, respectively, using OTC eye drops for more than 12 months.

CONCLUSION: PFHO patients reported high satisfaction with their medication, with a majority refilling their prescription. Most PFHO patients had prior OTC eye drop usage for more than 12 months, potentially identifying a subset of the patient population likely to benefit from the novel treatment.

PURPOSE:

When fitting toric soft contact lenses (CLs), characteristics important to eye care practitioners (ECPs) include ease of fitting, CL rotational stability, and high success for patients. The kalifilcon A daily disposable toric CL (INFUSE for Astigmatism [IfA]) is designed with OpticAlign Design and high-definition optics to deliver clear, stable vision, along with key ingredients to help support ocular surface homeostasis and wearer comfort. Here we report ECP experience and satisfaction in a real-world evaluation of fitting the IfA CL.

METHODS:

ECPs invited eligible astigmatic patients (≥18 years of age, either new or existing CL wearers) to be fitted with the IfA CL and then try this CL for a 5-day period. ECPs who fitted ≥3 patients with IfA CLs were provided with an online ECP-specific survey to report key aspects of their experience with this new CL, including visibility of the lens orientation mark, perceptions of CL stability, vision outcomes, patient comfort, and their overall satisfaction and opinion of the CL. A two-sided asymptotic binomial test assessed whether a favorable response was indicated in >50% of responses for key attributes.

RESULTS:

In total, 54 ECPs completed the study survey; 72.2% were members of an independent practice and 85.2% had been in practice for >5 years. By the time of survey completion, ECPs reported having fit a median of 20 patients each with the IfA CL. The reported experience of these ECPs was as follows: 92.6% agreed the IfA CL orientation mark was easy to see, 96.3% agreed the CL provided optimal CL stability, 94.4% agreed it delivered clear and stable vision, and 94.4% agreed it provided a comfortable CL wear experience for patients. Overall ECP satisfaction with, and opinion of, the IfA CL included that 94.4% were both completely or very satisfied with its performance and considered them to be excellent or very good overall. Favorable responses were statistically significantly greater than 50% for all of these key performance attributes (p<0.001).>

CONCLUSION:

These insights into ECP experience with the IfA CL demonstrate the robust performance and real-world success of this CL in practice, including fitting supported by orientation mark visibility, robust CL stability, vision and comfort outcomes achieved for their patients, and overall satisfaction with this unique toric CL.

PURPOSE:

The ability of a toric contact lens to properly orient on eye and maintain orientation is important for delivering optimal visual acuity and performance. Revive Toric (hioxifilcon D) soft contact lenses are engineered with a toric posterior surface specifically designed to correct astigmatism. In addition, Revive Toric lenses incorporate a specialized thin orientation zone, ensuring the lens remains correctly aligned throughout wear. This precise design is intended to enhance rotational stability, thereby providing visual performance and patient satisfaction for individuals with astigmatic refractive errors. The purpose of this study was to evaluate the visual performance and on-eye stability of Revive Toric contact lenses.

METHODS:

In this post-market, bilateral, repeated-measures study, experienced toric contact lens wearers were enrolled. At the screening/baseline visit, participants underwent baseline sphero-cylindrical refraction, high-contrast, high-illumination logMAR visual acuity, visual quality and corneal topography. Custom toric lenses were ordered according to the Revive Toric fitting guide. Eligible participants returned and lenses were dispensed. After a 10-minute settling period, visual acuity and lens fit (including centration and orientation) were evaluated. If vision and fit were acceptable, participants wore lenses for 8-16 hours per day for approximately 1 week. At the 1-week follow-up, visual acuity and lens fit parameters were re-assessed including rotational recovery (measured 60 seconds after manually rotating the lens to 45° temporal). Data was collected using standardized procedures and scales.

RESULTS:

32 participants were enrolled and 26 (12 female and 14 male; mean age 43.6 years) completed the study. Visual acuity and visual quality showed no statistically significant differences between baseline spectacle correction and contact lens-correction at both the dispensing and follow-up visits (p≥0.126 in all cases). Lens evaluations revealed consistent performance, with acceptable centration, lens movement, lens surface, and negligible oscillation with blink. At the dispensing visit, 69% of the lenses were oriented within 10° of the expected position, which improved to 85% at the 1-week follow-up. Moreover, 75% of the lenses demonstrated rotational recovery within 10° after 60 seconds.

CONCLUSION:

Revive Toric soft contact lenses delivered consistent visual acuity; outcomes were equivalent to baseline spectacle correction. Excellent lens fit and rotational stability were maintained over 1 week of daily wear.

PURPOSE: To document patient characteristics, diagnostic tests, and treatment of dry eye disease (DED) in patients outside of the clinical trial setting, leveraging real world evidence (RWE).

METHODS: Retrospective cohort study using the American Academy of Ophthalmology IRIS (Intelligent Research in Sight) Registry linked to pharmacy claims data. Patients were diagnosed with DED and initiated an index anti-inflammatory DED prescription therapy between Jan 1, 2017, and Dec 31, 2024.

RESULTS: The study included 143,005 patients with DED who initiated an anti-inflammatory DED therapy. The average age was 61 years, and most were female. Ocular comorbidities included cataracts (41%), glaucoma (9%), and age-related macular degeneration (5%). Non-ocular comorbidities included hyperlipidemia (45%), hypertension (43%), diabetes (21%), obstructive sleep apnea (11%), chronic obstructive pulmonary disease (6%) rheumatoid arthritis (6%) and Sjogren's syndrome (6%). Approximately 7% of patient eyes (n=19,654) had recorded tear film break-up time measurements, 2% (n=4,877) had Schirmer's, and 11% (n=29,830) had tear osmolarity tests. Prior to index therapy, 11% of patients had received a prescription (predominantly topical cyclosporine), and 8% punctal plugs. Clinicians included cataract/anterior segment subspeciality ophthalmologists (19%), cornea subspeciality ophthalmologists (14%), and comprehensive ophthalmologists (13%), as well as others, including optometrists (32%).

CONCLUSION: This study highlights the importance of RWE in understanding clinical characteristics, as well as diagnosis and treatment patterns, to inform future DED treatment strategies.

PURPOSE: Ocular lubricants are the cornerstone of dry eye (DE) management. Blink Boost (BB) is a preservative-free lubricating eye drop developed to provide fast-acting relief for DE. Formulated to mimic the natural composition of tears without the deleterious effects associated with common preservatives, BB is suitable for daily use, including by contact lens wearers. This study assessed patient outcomes and preferences following administration of BB.

METHODS: This was a prospective cross-sectional survey study of self-identified DE sufferers. Adult DE sufferers in the US were recruited online from a nationally representative consumer panel. Eligible participants had used over-the-counter artificial tears/lubricants in the prior 6 months, with confirmed DE symptoms documented at baseline by ocular surface disease index (OSDI) scores at screening. Prescription eye drop users were excluded, along with participants who had undergone ocular surgery within 6 months or were allergic to any formulation of eye drops. Enrolled participants received a masked bottle (unbranded) of BB drops with instructions to administer a drop(s) in the morning. Participants then completed questionnaires assessing product performance at four timepoints: immediately, and 4, 8, and 10 hours after instillation. The survey instrument measured patient reported outcomes including global symptoms, a set of DE-specific symptoms and treatment satisfaction.

RESULTS: A total of 622 participants screened were assigned to use BB (56% female; 74% aged 25–64 and 25% ≥65); 23.3% (n=145) were contact lens wearers. OSDI scores indicated mild (39.1%), moderate (30.8%) or moderate/severe (30.1%) participants. At screening, all participants used over-the-counter eye drops (artificial tears/lubricants); 33.6% (n=209) used them for allergies, and 38.1% (n=237) for eye redness. Participants reported immediate feelings of comfort and relief after using BB (agree/strongly agree: Comfortable 91%, Hydrating 90%, Soothing 87%, Relieving 84%). When patients were stratified by OSDI, mild, moderate, and moderate/severe sufferers (n=155, n=122, and n=119, respectively) reported similarly high levels of agreement with key performance attributes immediately after use: "my dry eyes feel better", 88%, 86%, and 87%, respectively; "these eye drops help to relieve my dry eyes", 86%, 82%, 88%, respectively; and "my dry eyes feel relieved", 88%, 82%, and 88%, respectively. BB performed well across all OSDI severity levels, with notably better performance in the moderate DE cohort.

CONCLUSION: These real-world findings highlight the immediate relief from DE symptoms provided by BB drops. These improvements in hydration, moisturization, comfort and symptom relief were achieved regardless of OSDI severity and were especially apparent in a cohort with moderate DE.