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Catherine A Scheuer, Vicki L Barniak, Nitasha R Phatak, Marjorie J Rah, William Reindel Vision Care, Bausch & Lomb Inc., Rochester, NY, USACorrespondence: Nitasha R Phatak, Vision Care, Bausch & Lomb Incorporated, Rochester, NY, USA, Tel +1 585 413-6397, Email Nitasha.Phatak@bausch.comPurpose: Interactions between tear proteins and the interfaces of contact lenses can be complex and can influence contact lens wear success. Tear proteins, including lysozyme, function to maintain the balance of ocular surface homeostasis, as evidenced by the effects of its conformation relative to stabilizing the tear film and its potential impact on corneal epithelial cells. Contact lens manufacturers include components in lens care and blister package solutions to help stabilize the tear film and preserve homeostasis. This in vitro study was performed to evaluate the ability of daily disposable contact lens package solutions to stabilize lysozyme and preserve its native conformation under denaturing conditions.Methods: Lysozyme was added to contact lens solutions sampled from kalifilcon A, etafilcon A, senofilcon A, narafilcon A, nelfilcon A, verofilcon A, delefilcon A, somofilcon A, and stenfilcon A blister packages, then mixed with the protein denaturant sodium lauryl sulfate. Lysozyme activity was evaluated by adding test solutions to a suspension of Micrococcus luteus. Native lysozyme lyses the Micrococcus luteus cell wall, which decreases suspension turbidity. Stabilization of lysozyme activity was determined by comparing suspension turbidity before and after exposure to test solutions.Results: Lysozyme stabilization was 90.7% for kalifilcon A solution, a statistically significant improvement (p < 0.05) compared to phosphate buffered saline (PBS, negative control). No significant improvement was observed with any other contact lens solution (all lysozyme stabilization < 5.00%).Conclusion: The representative tear protein lysozyme was significantly more stable in th

Jill Saxon, Marjorie J Rah, William T Reindel Vision Care, Bausch & Lomb Incorporated, Rochester, NY, USA Purpose: The purpose of this evaluation was to compare the experience of habitual contact lens wearers with that of nonwearers when fitted with a novel toric nesofilcon A contact lens (Biotrue ONEday for Astigmatism lens; Bausch & Lomb Incorporated, Rochester, NY, USA), for wearer comfort, vision, and satisfaction in a real-world setting.Materials and methods: Participating eye care practitioners (ECPs) prescribed toric nesofilcon A lenses to their astigmatic patients as part of their routine clinical practices. Accordingly, 1,253 patients successfully completed the evaluation; of these, 51% wore contact lenses habitually, 41% wore eyeglasses, and 8% had no prior vision correction. All wore the lenses for at least 4 days, and 74% wore them for an average of 9 hours or more per day. After at least 4 days of wear, each patient completed an online survey to evaluate his or her level of satisfaction regarding comfort and vision. As this postmarket evaluation was observational, data were analyzed to determine whether more patients than not agreed with individual statements regarding lens performance, and whether there was any difference in response between habitual contact lens wearers and nonwearers.Results: As a measure of general satisfaction, 96% of patients indicated that their overall opinion of the toric nesofilcon A lens was good to excellent. Further, more patients than not agreed that the lens performed well with regard to all aspects of vision and comfort queried (P<0.001). There was no difference in response between habitual contact lens wearers and nonwearers.Conclusion: All astigmatic patients with spherical contact lenses, other toric lenses, or eyeglasses, as well as those who had no prior correction, who had converted to the toric nesofilcon A lens expressed a high level of satisfaction with vision and comfort. ECPs should expe

Stephanie Su,1 Lynette Johns,2 Marjorie J Rah,3 Robert Ryan,1 Joseph Barr3 1Visionary Eye Associates of Rochester, Rochester, NY, USA; 2Custom Lab Channel Business, Bausch & Lomb Incorporated, Wilmington, MA, USA; 3Medical Affairs – Vision Care, Bausch & Lomb Incorporated, Rochester, NY, USA Purpose: This study evaluated the clinical performance of KeraSoft® IC (KIC) soft contact lenses in subjects with irregular corneas.Patients and methods: This was a 12-month, prospective, open-label, observational study, which enrolled 43 subjects who were 18 years of age or older with irregular corneas. Subjects were fit according to the KIC Fitting Manual (kerasoftic.com). After achieving best fit according to the fitting manual, lenses were assessed for comfort, vision, centration, rotation, and movement. Subjects were instructed to wear their lenses between 8 and 16 hours each day. Assessments at the exit visit included logMAR visual acuity with high and low contrast, spherocylindrical overrefraction, slit-lamp findings, adverse events, and subjective outcomes.Results: The average base curve was 8.17±0.32 mm (n=70 eyes), and the average diameter dispensed was 14.53±0.12 mm (n=70 eyes). From the baseline to 12 months, there was statistically significant improvement in logMAR visual acuity with high contrast (P=0.038), but no significant difference in low-contrast visual acuity was observed (P>0.05). Slit-lamp findings were ≤ grade 1 for the majority of subjects (89%). Two nonserious adverse events were reported for two of the 84 enrolled eyes (two subjects). At 12 months, subjects reported improvements from habitual baseline for comfort and vision, both upon insertion and just before removal of lenses.Conclusion: Clinical outcomes at 12 months showed good visual, safety, and subjective outcomes for subjects with corneal irregularities who wore KeraSoft® IC soft contact lenses. Keywords: irregular co

Jeffery Schafer, Robert Steffen, Marjorie J Rah Bausch & Lomb Incorporated, Rochester, NY, USA Purpose: We aimed to evaluate the product performance of a novel one-step hydrogen ­peroxide cleaning and disinfecting solution, PeroxiClear (“Test” solution), when used by habitual Clear Care users to bilaterally clean and disinfect their soft contact lenses, for approximately 2 weeks.Methods: This was a 2-week, open-label, bilateral eye study designed to include subjects ­ranging in age from 18 to 55 years, inclusive. All subjects were habitual users of the Clear Care peroxide regimen for cleaning, disinfecting, and storage of their soft contact lenses, for at least 6 months prior to enrolling in the study. Subjects were examined at two study visits: a screening/­dispensing visit and a 2-week follow-up visit. The primary end point, patient preference for the Test solution, was evaluated with an online survey administered after 7 days of using the Test cleaning and disinfecting solution. Respondents could answer questions with neutral or nonneutral responses (better or worse). Statistical analyses were conducted to compare differences for nonneutral responses.Results: Of the 299 eligible subjects enrolled, 297 completed the study, conducted at 21 sites by 21 investigators in the United States. A significantly higher proportion of nonneutral respondents reported the Test solution was better overall (85.9%) than their habitual contact lens solution (14.1%) (P<0.001). The proportion of subjects who preferred the Test solution over their habitual solution was significantly higher for each of the preference questions regarding comfort (85.4% vs 14.6%), moistness (90.0% vs 10.0%), cleanness (91.6% vs 8.4%), and clarity of vision (85.8% vs 14.2%).Conclusion: After 7 days of using the Test cleaning and disinfecting solution, survey results indicated high levels of patient satisfaction and prefer

Jeffery M Schafer, William T Reindel, Marjorie J Rah, Osbert Chan, Lening Zhang Bausch & Lomb Incorporated, Rochester, NY, USA Purpose: The purpose of this evaluation was to compare the performance characteristics of two cosmetically tinted contact lenses in the circle lens category that differ in lens design, lens material, and pigment print pattern: etafilcon A (1-Day Acuvue Define; Johnson & Johnson Vision Care) and hilafilcon B (Naturelle; Bausch & Lomb Incorporated). Methods: Two hundred Asian subjects (400 eyes) were enrolled in this 1-month parallel, bilateral, randomized study at ten investigative sites. Study lenses were dispensed at a screening/dispensing visit, and follow-up visits occurred at 2 weeks and 1 month. Lenses were worn on a daily disposable basis. Fit characteristics were evaluated at each visit, and slit-lamp evaluations were completed at each follow-up visit. Results: Of the 200 patients enrolled, 172 (344 eyes) completed the study. The proportion of eyes with fully centered lenses was statistically significantly higher for the hilafilcon B group at the 2-week and 1-month visits, P<0.05. Over all visits, 0.6% of hilafilcon B eyes demonstrated incomplete corneal coverage, whereas for the etafilcon A group, 8.5% of eyes demonstrated incomplete corneal coverage and/or edge lift. The proportion of eyes with adequate lens movement was statistically significantly higher for the hilafilcon B group, P<0.05. Over all visits, none of the hilafilcon B eyes was reported to have excessive movement, whereas for etafilcon A lenses, 10.2% of eyes were reported to have excessive movement. Conclusions: Etafilcon A lenses were significantly less likely to be fully centered and significantly more likely to have incomplete corneal coverage and/or edge lift compared with the hilafilcon B lenses. Keywords: cosmetic contact lens, circle contact lens

Marjorie J Rah, Mohinder M Merchea, Marianne Q DoktorBausch & Lomb Incorporated, Rochester, NY, USAPurpose: To evaluate whether the use of Biotrue multipurpose solution (MPS) could significantly reduce the likelihood with which patients drop out of using daily wear contact lenses (CLs) amongst 18–44-year-old frequent replacement CL wearers.Methods: Daily wear CL subjects habitually using MPSs (other than Biotrue MPS) who reported an intent to imminently drop out of CL wear because of comfort and dryness complaints were recruited to participate in this investigation. Subjects were switched to Biotrue MPS and continued to use habitual CL types with the new MPS for 2 weeks. Subjects completed an online satisfaction questionnaire at baseline and after 2 weeks to assess the change in symptoms and the intent to drop out of CL wear. Six months after completion of the initial study, a follow-up survey was administered to a subset of the initial participants.Results: A total of 153 daily wear (silicone hydrogel and hydrogel) subjects completed this 2-week study with Biotrue MPS. When measuring those with the highest propensity to drop out of lens wear (n=93) after switching to Biotrue MPS, 90% of subjects significantly reduced their likelihood of dropping out of CL wear (P<0.0001). Online interviews were conducted with 73 of the study participants 6 months after completion of the initial study. A total of 93% of participants responded that they were still wearing CLs at least once per week. Of the 7% of respondents who were not currently wearing lenses 6 months after the initial study, two had dropped out of lens wear completely, and three still wore lenses less than once per week.Conclusion: Patients intending to drop out of CL wear due to discomfort and dryness significantly reduced their propensity of discontinuing lens wear following use of Biotrue MPS. Six months after completion of the study, 93% of patients were still wearing CLs at least once

Marjorie J Rah,1 Jeffery Schafer,1 Lening Zhang,1 Osbert Chan,2 Lipika Roy,3 Joseph T Barr11Bausch & Lomb Incorporated, Rochester, NY, USA; 2Bausch & Lomb Incorporated, Asia Pacific Medical Affairs, Hong Kong; 3Bausch & Lomb Incorporated, Asia Pacific Medical Affairs, Singapore, MalaysiaBackground: Concerns regarding the safety of cosmetically tinted contact lenses have been reported in the literature. The purpose of this paper is to evaluate the safety of cosmetically tinted contact lenses in a large number of patients across six clinical trials that varied from 1 week to 3 months in duration.Methods: Lenses tested included: Naturelle limbal ring daily disposable, Lacelle limbal ring daily disposable, Lacelle colored cosmetic daily disposable, Lacelle limbal ring planned replacement at 2 weeks, and Alamode traditional/annual colored cosmetic lens. The primary safety outcome was slit-lamp examination, including epithelial edema, epithelial microcysts, corneal staining, bulbar injection, limbal injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates. High contrast logMAR visual acuity with lenses, and lens wearing time, movement, and centration, are also presented.Results: A total of 871 subjects (1,742 eyes) and 23 clinical investigators participated in the six studies, with an average completion rate of 96.4% across all studies. The mean age of the patients was 26.8 ± 6.6 years, and 86.7% of participants were female. The total number of slit-lamp examinations across the six studies was 2,456 visits by eye (1,228 visits by patient). There were no slit-lamp signs > grade 2 for any finding, with the exception of corneal staining in one study. In this study, grade 3 corneal staining was noted in one eye (0.1%) at follow-up visit 1 and four (0.6%) of all eligible dispensed eyes at follow-up visit 2, with no eyes requiring medical treatment. No adverse events were reported durin

William Reindel, Mohinder M Merchea, Marjorie J Rah, Lening Zhang Bausch & Lomb Incorporated, Rochester, NY, USA Background: The purpose of this paper is to evaluate the biocompatibility of a novel multipurpose solution (MPS) with a dual disinfectant system containing polyaminopropyl biguanide and polyquaternium-1 (Biotrue®) by analysis of biomicroscopy signs and adverse events in six large clinical trials. Methods: Data from six consecutive, prospective clinical trials conducted from February 2008 to March 2010 were combined for meta-analysis. Subjects used the new MPS daily for periods of 2 weeks to 6 months. Slit-lamp signs were graded at each follow-up visit using an ordinal scale (0, one; 1, trace; 2, mild; 3, moderate; 4, severe). Analysis for biocompatibility included tracking of greater than grade 2 slit-lamp findings and number of adverse events. Results: A total of 1,567 subjects (3,134 eyes) and 81 clinical investigators participated in the six studies, with 1,499 subjects completing the studies. Based on subject days in the studies, there were 72,904 exposures to the MPS and 7,212 biomicroscopy examinations. The completion rate for the studies was 96.3%. Per observation incidence of any finding greater than grade 2 at the follow-up visits were: corneal staining 0.08%, limbal injection 0.04%, bulbar injection 0.04%, tarsal conjunctiva abnormality 0.09%, and neovascularization 0.01%. There were no other slit-lamp signs greater than grade 2 and no statistically significant difference between hydrogels and silicone hydrogels for any finding. There were no reports of adverse events during the trials. Conclusion: Analysis of over 72,000 daily exposures and 7,212 eye examinations showed that the novel MPS exhibited excellent biocompatibility in subjects using daily wear hydrogel or silicone hydrogel lenses. Keywords: contact lens, solutions, disinfection, meta-analysis, silicone, hydrogel