Jason J Nichols1. 1. The Ohio State University, College of Optometry, Columbus, Ohio 43210, USA. Nichols.142@osu.edu
Abstract
PURPOSE: The purpose of this study is to investigate the frequency of deposition and impact of various multipurpose care regimens on a silicone hydrogel contact lens material (galyfilcon A; Acuvue Advance, Vistakon, Inc.). METHODS: This was a two-phase, monadic, open-label, daily-wear clinical study. The analyses from Phase I were aimed at determining total lens front surface area deposition after two 2-week periods of galyfilcon A lens wear. Deposition was graded clinically using a slit-lamp biomicroscope from grade 0 (0% surface area) to grade 4 (>25% surface area). Secondary outcomes included visual acuity and self-reported overall comfort, end-of-day comfort, and perceived vision. Phase II determined the impact of various multipurpose solutions with and without a rub step on "heavy depositors" (grade 3 or 4) from a single phase I site. There were four arms associated with phase II, and front surface deposition was again the primary outcome with the same secondary outcomes as that mentioned previously. RESULTS: In phase I, after the initial 2-week wear period, 9.4% of subjects exhibited grades 3 and 4 deposition. There were no differences in visual acuity, comfort, end-of-day comfort, and self-reported perceived vision when comparing "depositors" and "nondepositors." Twenty-seven "heavy depositors" from phase I completed phase II. After using Complete MoisturePlus (with a digital rub), no patients (0%) had clinically significant (grades 3 or 4) deposition, whereas for comparison, 33% of patients (the "heavy depositors") from phase I had clinically significant deposition without a digital rub (p=0.003). Similarly, 3.7% of patients had grade 3 or 4 deposition after using Opti-Free Express (with a digital rub) (p=0.01) and AOSEPT with a Miraflow-based rub (p=0.01) compared with the 33% of patients using Complete MoisturePlus without a digital rub. There were no differences in visual acuity or self-reported outcomes when stratified by lens care system in phase II. CONCLUSIONS: Less than 10% of subjects exhibit clinically significant levels of deposition with galyfilcon A lenses when cleaned with Complete MoisturePlus (no-rub) multipurpose solution, and this was shown to not interfere with lens performance. The addition of a rub-and-rinse step to the care of galyfilcon lenses significantly reduces this deposition rate.
PURPOSE: The purpose of this study is to investigate the frequency of deposition and impact of various multipurpose care regimens on a silicone hydrogel contact lens material (galyfilcon A; Acuvue Advance, Vistakon, Inc.). METHODS: This was a two-phase, monadic, open-label, daily-wear clinical study. The analyses from Phase I were aimed at determining total lens front surface area deposition after two 2-week periods of galyfilcon A lens wear. Deposition was graded clinically using a slit-lamp biomicroscope from grade 0 (0% surface area) to grade 4 (>25% surface area). Secondary outcomes included visual acuity and self-reported overall comfort, end-of-day comfort, and perceived vision. Phase II determined the impact of various multipurpose solutions with and without a rub step on "heavy depositors" (grade 3 or 4) from a single phase I site. There were four arms associated with phase II, and front surface deposition was again the primary outcome with the same secondary outcomes as that mentioned previously. RESULTS: In phase I, after the initial 2-week wear period, 9.4% of subjects exhibited grades 3 and 4 deposition. There were no differences in visual acuity, comfort, end-of-day comfort, and self-reported perceived vision when comparing "depositors" and "nondepositors." Twenty-seven "heavy depositors" from phase I completed phase II. After using Complete MoisturePlus (with a digital rub), no patients (0%) had clinically significant (grades 3 or 4) deposition, whereas for comparison, 33% of patients (the "heavy depositors") from phase I had clinically significant deposition without a digital rub (p=0.003). Similarly, 3.7% of patients had grade 3 or 4 deposition after using Opti-Free Express (with a digital rub) (p=0.01) and AOSEPT with a Miraflow-based rub (p=0.01) compared with the 33% of patients using Complete MoisturePlus without a digital rub. There were no differences in visual acuity or self-reported outcomes when stratified by lens care system in phase II. CONCLUSIONS: Less than 10% of subjects exhibit clinically significant levels of deposition with galyfilcon A lenses when cleaned with Complete MoisturePlus (no-rub) multipurpose solution, and this was shown to not interfere with lens performance. The addition of a rub-and-rinse step to the care of galyfilcon lenses significantly reduces this deposition rate.