Clinical performance of a peroxide-based care system & a multi-purpose care system formulated for use with SiHs

Nancy Keir, Simone Schneider, Kathryn Dumbleton, Craig A Woods, Yunwei Feng

Purpose: To investigate the clinical performance of a peroxide-based care system (CIBA Vision ClearCare - CC) and a multi-purpose lens care system formulated for use with silicone hydrogels (Alcon Opti-Free RepleniSH - OFR), when used with two silicone hydrogel lens materials.

Methods: This study was a daily wear, contralateral eye (lens), clinical trial, with a single-masked and randomized crossover (care system) design. Data were collected at 7 visits (baseline, 2wks and 4wks/phase). Subjects wore lotrafilcon B (O2Optix - O2) and senofilcon A (OASYS - OA) contralaterally, with 2wk replacement for each lens type. Assessments included biomicroscopy, graded in-eye lens wettability and graded front surface deposition (0-4 scales). Fluorophotometry was conducted at 2wks and confocal microscopy at 4wks. Subjective ratings, comfortable wearing times (CWT), and a “final preference” questionnaire were completed.      
 
Results: Twenty-four subjects completed the study. Fluorophotometry, confocal microscopy, and corneal staining showed no difference between solutions (all p>0.05). CC resulted in significantly longer CWT than OFR (10.75±1.71 vs 9.80±1.53 hours; p<0.01), however there was no difference in subjective comfort ratings (p>0.05). CC was preferred over OFR for maintaining clear vision (p<0.05), reducing end-of-day redness with OA (p<0.01) and for overall performance with O2 (p<0.05). Although perhaps not clinically relevant, wettability and deposition were better with OFR vs. CC for OA (0.95±0.7 vs 1.42±1.0; p=0.01 and 0.33±0.5 vs 0.60±0.7; p=0.03, respectively) with no difference between solutions for O2 (both p>0.05).
 
Conclusions:  This study demonstrated that subjects preferred CC over OFR, and that CC resulted in a longer CWT, regardless of lens type. Slightly better graded wettability and fewer visible deposits seen on OA with OFR were not associated with longer CWT, suggesting that these investigator assessed measures do not predict comfort.
 

Financial support was provided by CIBA Vision, Inc.