PURPOSE: To compare two preservative-free hydrating agents, in multidose (ABAK) bottles, in contact lens wearers experiencing symptoms of ocular dryness. METHODS: The endpoint of this 4-week multicenter, randomized, double-blind, parallel-group study comparing a 2% polyvinylpyrrolidone (PVP) solution with a 0.9% NaCl solution was to assess ocular discomfort using a visual analog scale. A biomicroscopic examination and a test of tolerability on instillation were also performed, and adverse events were recorded. RESULTS:Thirty-nine subjects were enrolled (23 PVP; 16 NaCl). The average age was 30; subjects were predominantly female, and mostly wore frequent-replacement contact lenses. They were all exposed to environmental factors such as routine use of video monitors or air conditioning. The two groups were similar at baseline (D0). Both PVP and NaCl improved the comfort of contact lens wear (P = 0.0003), with no difference between them (P = 0.25). The mean daily duration of lens wear and the daily number of instillations to relieve discomfort (4.2 +/- 2.0 for PVP ABAK; 4.6 +/- 1.9 for NaCl ABAK) were comparable. However, PVP use led to more favorable evolution of fluorescein-staining corneal punctuations (P = 0.028). Safety was good, with minimal adverse events considered unrelated to the products. Lens wettability was excellent, and there were no clinically relevant deposits. Most subjects also found the ABAK bottles convenient. CONCLUSIONS:Ocular hydration improves comfort in contact lens wearers. NaCl is an appropriate first-line treatment, but for subjects with fluorescein-staining punctuations, lubrication with PVP is preferable.
RCT Entities:
PURPOSE: To compare two preservative-free hydrating agents, in multidose (ABAK) bottles, in contact lens wearers experiencing symptoms of ocular dryness. METHODS: The endpoint of this 4-week multicenter, randomized, double-blind, parallel-group study comparing a 2% polyvinylpyrrolidone (PVP) solution with a 0.9% NaCl solution was to assess ocular discomfort using a visual analog scale. A biomicroscopic examination and a test of tolerability on instillation were also performed, and adverse events were recorded. RESULTS: Thirty-nine subjects were enrolled (23 PVP; 16 NaCl). The average age was 30; subjects were predominantly female, and mostly wore frequent-replacement contact lenses. They were all exposed to environmental factors such as routine use of video monitors or air conditioning. The two groups were similar at baseline (D0). Both PVP and NaCl improved the comfort of contact lens wear (P = 0.0003), with no difference between them (P = 0.25). The mean daily duration of lens wear and the daily number of instillations to relieve discomfort (4.2 +/- 2.0 for PVP ABAK; 4.6 +/- 1.9 for NaCl ABAK) were comparable. However, PVP use led to more favorable evolution of fluorescein-staining corneal punctuations (P = 0.028). Safety was good, with minimal adverse events considered unrelated to the products. Lens wettability was excellent, and there were no clinically relevant deposits. Most subjects also found the ABAK bottles convenient. CONCLUSIONS: Ocular hydration improves comfort in contact lens wearers. NaCl is an appropriate first-line treatment, but for subjects with fluorescein-staining punctuations, lubrication with PVP is preferable.