Ocular tolerance of a new multipurpose solution specifically formulated for daily wear of silicone hydrogel contact lenses.

PURPOSE: To evaluate the safety, physiological performance, and effect on ocular tissues of a new multipurpose disinfecting solution (MPDS) specifically formulated for use with silicone hydrogel (SH) contact lenses (CL). METHODS: Two MPDS [solution A (Solo-care Aqua(®), Ciba-Vision) and solution B (Hidro Health(®), Disop)] were randomly assigned and prescribed in a clinical trial in a crossover clinical trial (Registered #293/07/EC; Spanish National Health Department). Only lotrafilcon B CL daily wearers were included. After each solution was used, a masked investigator assessed the slit-lamp findings (SL9, Topcon Inc.), lens deposits, and wettability according to the Guidance for clinical investigation (ISO 11980). CL daily wearing time (hours per day and days per week) were recorded. RESULTS: Fifty-four daily wearers were included. Average CL wear time was 8.3 ± 2.3 (CI95% 7.9-8.7) hours per day (8.5 ± 2.7 at baseline visit, 8.2 ± 1.9 with solution A, and 8.4 ± 2.2 with solution B). The average number of days per week of CL wear was 5.9 ± 1.3 (CI95% 5.6-6.1) (5.4 ± 1.6 at baseline visit, 6.1 ± 0.9 with solution A, and 6.0 ± 1.1 with solution B). Non-adverse slit-lamp findings were recorded (higher than 2 points). No statistical difference (P>0.05 Friedman test) in CL wearing time, number of days of CL wears and slit-lamp findings were found between the two solutions. CONCLUSIONS: This clinical trial shows that the new formulation of Hidro Health(®) MPDS is safe when used for the care of daily-wear lotrafilcon B CL. This new solution has no clinical significance on ocular tissues, according to the Guidance for clinical investigation (ISO 11980).

Differences in the daily symptoms associated with the silicone hydrogel contact lens wear.

OBJECTIVE: To determine the differences in symptoms associated with daily wear of silicone hydrogel (lotrafilcon B) contact lenses (CLs) after CL insertion and at the end of wear and their relationship with environmental factors and multipurpose solutions (Solo-care Aqua, CIBA Vision, Duluth, GA and Hidro Health, Disop, Spain). METHODS: Fifty-four patients were fitted with lotrafilcon B CLs. Two multipurpose solutions were randomly assigned and prescribed in a double-masked crossover study with three visits. After each solution was used, two questionnaires were conducted, including a survey produced by us and Contact Lens Dry Eye Questionnaire. Our questionnaire included 10 items addressing discomfort, blurry vision, lens-handling problems, dryness, redness, tearing, burning, itching, discharge, and dissatisfaction. Patients were assigned scores from 0 (without symptoms) to 10 (symptoms unbearable) at two different times (after CL insertion and at the end of wear) and in two environments (outdoors and adverse environments). RESULTS: The average duration of CL wear was 8.32 +/- 2.27 hr/day and 5.85 +/- 1.30 days/week. All symptoms became worse (P < 0.05 Wilcoxon test, except lens handling) at the end of CL wear in all visits. The results were independent of the multipurpose solution used (P > 0.05 Friedman test), except for tearing, which showed statistical differences between visits (P = 0.03 Friedman test). Contact Lens Dry Eye Questionnaire showed increased dry eye symptoms at the end of wear (P < 0.05 Friedman test). CONCLUSIONS: Daily wear symptoms associated with lotrafilcon B CL increase with the time of wear. This increase in symptoms is nonrelated with the multipurpose solutions compared in this study.