CLINICAL EFFICACY AND SAFETY OF NO RUB™ MULTI-PURPOSE DISINFECTING SOLUTION WITH ALL LENS REPLACEMENT SCHEDULES

Evan Thomas

Abstract

PURPOSE. Daily manual rubbing has historically been regarded as an essential step in maintaining soft lens cleanliness and disinfection. Patients, however, find manual rubbing inconvenient and often skip this step of the daily care routine. Furthermore, the additional handling during rubbing can result in tearing of the lenses. This clinical study evaluated the safety and efficacy of an enhanced multi-purpose disinfecting solution (mpds) used without manual rubbing compared with a popular multi-purpose solution (mps) with rubbing. METHOD. This was a 90-day, patient-observer masked study. One hundred and fifty-seven daily-wear Group I (Preference) and IV (Frequency 55) contact lens wearers were enrolled at 10 sites. Patients were randomly assigned to Regimen 1 [OPTI-FREE EXPRESS MPDS without a daily manual rubbing step (OFX MPDS)] or Regimen 2 (ReNu MultiPlus MPS with daily rubbing). The regimens were evaluated at baseline (Day 0) and on Days 14, 30, 60 and 90.

RESULTS. Group IV lenses cared for with Regimen 1 (No Rub) had significantly less laboratory-measured residual lysozyme at Day 90 (556 micrograms) than lenses cared for with Regimen 2 (with manual rubbing; 822 micrograms, p < 0.0001). Lens wearing time, visual acuity, subjective lens cleanliness and ocular comfort were maintained consistent with baseline values and were similar between the regimens. A significant worsening of tarsal scores was noted at Day 90 for Regimen 2 Group IV lens wearers (p < 0.05). Ocular health was maintained with use of Regimen 1 (No Rub OFX MPDS).

CONCLUSIONS. Formulation advances allow use of a simplified lens care regimen, providing an improved wearing experience while maintaining high capacity disinfection, superior lens cleanliness and ocular health. OFX MPDS has received FDA clearance for use without manual rubbing with all soft lenses and replacement schedules.

Details

Year: 2001

Program Number: Poster 146

Author Affiliation: Independent Optometrist

Co-Authors: Robert Davis, Barry Eiden, David Evans, Richard Evans, Greg Friederichs, Jane Ireland, Dagmar Lutzi, Lee Rigel, Rex Roberson

Co-Author Affiliation: n/a

Room: Exhibit Hall C