The Efficacy of a Citrate-based Multipurpose Solution

(for Lenses Prescribed for Six Week Replacement)

ROBERT BEVINGTON, O.D., RONALD KREFMAN, O.D., & THOMAS CUSHING, O.D.
MAY 1996

Fifty-four patients wearing daily wear soft contact lenses of brands commonly used in bi-weekly or monthly replacement programs, participated in a six-week open-label, home-use study of Opti-One Multi-Purpose Solution. More than 96 percent of the lenses worn during the study were free of visible deposits at the end of six weeks.

METHODS

Our study participants -- 16 males and 38 females between the ages of 14 and 61 -- were experienced soft contact lens wearers with healthy eyes requiring optical correction. They used Opti-One Multi-Purpose Solution with Opti-One rewetting drops and an Opti-zyme enzyme tablet weekly, if needed. They were examined on days 14, 30 and 42 of the study.

CLEANING

We evaluated our subjects' lenses at the initial study visit and at each follow-up visit. We assessed lens cleanliness using a modified Rudko procedure based on the general visibility of any film or crystalline deposits, their specific appearance and the area of the lens covered by the deposits.

The study lenses remained clinically clean with 96 percent of the lenses having no visible deposits. None of the lenses had to be replaced due to deposits and patient comfort was maintained throughout the six-week period.

Some practitioners believe that multipurpose solutions must incorporate surfactants to adequately clean lenses worn for more than two weeks; the results of our study, however, show that this is not the case. For more than 90 percent of the patients, Opti-One, used without an enzymatic cleaner, kept lenses clean for the six-week period. The cleaning agent in Opti-One effectively removes protein while lenses are soaking as well as during the rub and rinse step.

COMFORT AND SAFETY

No clinically significant slit lamp findings were observed among the 54 patients in this study. The incidence of positive findings for corneal edema, neovascularization, staining, limbal injection, tarsal abnormalities or other complications was at or below baseline throughout the study. Also, there were no adverse events related to the study regimen.

At each visit, all of the patients reported that their lenses were very comfortable or comfortable. When asked specifically about burning, stinging, lens dryness and lens awareness, only three patients reported burning, stinging or lens awareness that was worse than they experienced with their pre-study regimen. None of these experiences related to the study regimen. Although lenses worn for 90 days may be more comfortable when a separate daily cleaner is part of the daily lens care regimen, our results show that Opti-One is an appropriate choice for the care of lenses designed to be replaced more frequently.

CONCLUSION

The findings from this study show that the Opti-One regimen is safe and effective when used with lenses worn for six weeks. These results support other studies that have shown the effectiveness of Opti-One when evaluated clinically and in laboratory settings. CLS

This study was sponsored by Alcon Laboratories.

Dr. Bevington has performed FDA clinical trials for Alcon and other contact lens manufacturers for over 15 years. He also frequently lectures and consults on refractive surgery. He is in group practice in Akron, Ohio.