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.