A two-week clinical evaluation of the safety of Systane® Ultra in contact lens-wearing patients
Specialty Eyecare Group, Kirkland, WA, USA
Objective: To evaluate the safety of Systane® Ultra Lubricant Eye Drops (test solution) in contact lens wearers. A currently marketed contact lens rewetting drop was the control solution.
Participants: This investigator- and patient-masked, single-site, randomized, and prospective study involved 45 successful contact lens wearers.
Methods: Eligible subjects’ baseline biomicroscopy findings, visual acuity, and corneal staining score were recorded. Subjects received either the test or control solution with masked labeling. Subjects were instructed to instill their assigned solution in both eyes: 15 minutes prior to lens insertion, at least one drop during lens wear and another drop immediately following lens removal. After 14 days, biomicroscopy results, visual acuity, and corneal staining score were recorded.
Results: No adverse events were documented for either the test or the control solution. For subjects using Systane® Ultra, no statistically significant change was detected in visual acuity (= 0.7667) or corneal staining score (P = 1.000). For subjects using the control solution, the change in visual acuity (P = 0.0011, mean difference = 1.70 ± 3.22 standard deviation) was not clinically relevant and there was no significant change in corneal staining score (P = 0.5413).
Conclusions: This clinical study provided evidence of safety and compatibility of Systane® Ultra Lubricant Eye Drops in contact lens wearers.
Keywords: lubricant eye drop, contact lens, safety, dry eye
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