United States
Content provided by Bausch + Lomb Medical Affairs.
Content provided by Bausch + Lomb Medical Affairs.
A key congress for contact lens specialists. Bausch + Lomb participated with 11 abstract presentations across the contact lens portfolio, including innovations in Bausch + Lomb INFUSE® and Bausch + Lomb ULTRA® multifocal/multifocal toric lenses featuring the 3-Zone Progressive design, alongside lens care disinfection data on Biotrue® Hydration Plus and NBR03 with additional specialty lens content on Zenlens® and Arise™.
PURPOSE: As patients age, they experience both the onset of presbyopia and a greater likelihood of symptoms of dry eyes. Here, the visual performance, comfort, and safety results are presented from a 3-week, prospective, open-label, multicenter study (NCT05660577) evaluating the kalifilcon A daily disposable multifocal contact lens (CL) in a subset of subjects with self-reported dry eyes at baseline.
METHODS: Habitual multifocal CL wearers ≥40 years of age with near-add requirements of +0.75 to +2.50 D were fitted with kalifilcon A multifocal CLs to be worn daily for 3 weeks, with scheduled in-office visits at 1 and 3 weeks. The pre-specified cohort with self-reported dry eyes per study baseline questionnaire was evaluated as a subgroup of interest (N=89 subjects/178 eyes). The primary outcome measure was the proportion of subjects agreeing that the CLs provide clear vision near, far, and in-between. Supportive endpoints included ratings of comfort, overall visual performance, (absence of) CL dryness, and overall impression (0–100 scale; 100=most favorable). Safety outcomes included adverse events (AEs).
RESULTS: In this cohort, 84.7% of those with an opinion agreed the CLs provide clear vision near, far, and in-between. For overall comfort, end-of-day comfort, overall visual performance, (absence of) CL dryness, and overall impression, subjects gave the study CL respective mean ratings of 91.9, 83.1, 85.0, 86.1, and 88.5 at the 1-Week visit and 93.4, 85.7, 87.0, 87.4, and 89.7 at the 3-Week visit; compared to their habitual (prior) CL ratings, mean study CL ratings at the 3-Week visit improved +16.6 in overall comfort, +26.0 in comfort at end of day, +12.8 in overall visual performance, +21.7 in (absence of) CL dryness, and +14.1 in overall impression. No serious AEs were reported.
CONCLUSIONS: Kalifilcon A daily disposable multifocal CLs were well-tolerated and demonstrated high visual performance and improved comfort in presbyopic individuals with self-reported dry eyes.
PURPOSE: A new dual disinfectant multi-purpose solution (MPS) was evaluated to determine the disinfection efficacy against bacterial and fungal organisms associated with microbial keratitis.
METHODS: The new borate-free investigational MPS (0.00015% polyquarternium-1 (PQ-1) and 0.0003% alexidine dihydrochloride) was tested for disinfection efficacy per ISO 14729 methodology using bacterial microbes Staphylococcus aureus (Sa), Pseudomonas aeruginosa (Pa), Serratia marcescens (Sm), and fungal microbes Candida albicans (Ca), and Fusarium solani (Fs), prepared with and without organic soil. These bacterial and fungal organisms were used to challenge the investigational MPS, and after 4 hours of disinfection each test solution was plated in triplicate and incubated. Plates were enumerated for the recovery of organisms and log reduction values (LRV) were calculated (with primary acceptance criteria per ISO 14729 being LRV of 3.0 [bacteria] and 1.0 [fungi]) and analyzed with Graphpad Prism.
RESULTS: The mean LRVs for the bacterial organisms (Sa, Pa, and Sm) without organic soil were 4.7, 4.6, and 4.6, and with the incorporation of organic soil the LRVs were 4.6, 4.6, and 4.5, respectively. The fungal organisms (Ca and Fs) without organic soil showed mean LRVs of 3.4 and 4.4, and with the incorporation of organic soil the mean LRVs were 3.8 and 4.3, respectively.
CONCLUSIONS: This new dual disinfectant MPS was efficacious and exceeded the ISO 14729 primary acceptance criteria for each challenge organism even in the presence of organic soil. This investigational MPS demonstrated robust disinfection per ISO 14729 against bacterial and fungal organisms.
PURPOSE: This study evaluated power profiles of the kalifilcon A multifocal (MF) contact lens (CL) relative to several other commercially available daily disposable MFCLs to understand differences in zone-specific power variance across the available power range, particularly at near and distance.
METHODS: Radial power profiles were measured using LAMBDA-X NIMO for commercially available add powers of 8 different daily disposable CLs: kalifilcon A (UODMF), nelfilcon A (DAQP MF), delefilcon A (DT1 MF), somofilcon A (C1D MF), etafilcon A (1DAM MF), stenfilcon A (MD MF), omafilcon A (PC1D MF), and senofilcon A (AOM1D MF). Measurements were obtained for multiple sphere powers (ranging from -9.00D to +6.00D; target n=8 CLs each). Data were normalized to the -3.00D intermediate zone and the overall total power variation (max-min) at the near zone (0.30 to 0.70 mm) and distance zone (2.60 to 3.00 mm) across the sphere power range and add powers were calculated for each product.
RESULTS: Overall, the observed power variability across the powers tested ranged from 0.107D to 0.336D for near zones and 0.061D to 0.737D for distance zones. The overall normalized variance data analysis showed that the UODMF lenses had statistically significantly (p<0.05) lower overall power profile variation across the power range compared to all lenses and numerically lower than the senofilcon a multifocal lens aom1d mf p="0.115).">
CONCLUSIONS: The normalized variance analysis demonstrated that UODMF lenses exhibited significantly less overall power profile variation across the available power range compared to most other daily disposable multifocal lens designs. The observed variability in power profiles across daily disposable MFCLs may also help further explain some of the various fitting recommendations provided by the respective manufacturers of these CLs today. Further research could explore the clinical implications of these findings in real-world patient populations.
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