Safety and comfort evaluation of a new formulation of Visine® lubricant eye drops containing HydroBlend™ and GentlePur™

PURPOSE To evaluate the clinical safety and comfort of a new benzalkonium chloride-free Visine(®) lubricant eye drop formulation (Hydroblend™ and GentlePur™) in healthy and dry eye subjects. METHODS This was a single-site, open-label clinical study comprised of 22 healthy and 22 dry eye subjects. Subjects were instructed to instill 1-2 drops of the test product four times a day for 2 weeks and were examined at visit 1 (day 0), visit 2 (day 7), and visit 3 (day 14). Assessments at each visit included postdosing product usage comfort scores, predosing fluorescein corneal staining score, predosing visual acuity, and pre- and postdosing ocular structure change using slit-lamp biomicroscopy. Adverse events were monitored throughout the course of the study. RESULTS Throughout the 14 days of the trial period, subjects from both healthy and dry eye groups rated the eye drops as "very comfortable". For dry eye group, the mean product usage comfort scores for the first 3 minutes postdosing ranged from 8.5 to 8.8 at visit 1 and 9.2 to 9.6 at visit 3 on a 0-10 point scale, with 0 being very uncomfortable and 10 being very comfortable. The mean corneal staining scores over five corneal regions changed from 0.65 at visit 1 to 0.39 at visit 3 for dry eye group. The individual region corneal staining scores were also decreased from visits 1 to 3 for dry eye group. All subjects maintained pretreatment means visual acuity at visits 2 and 3. Biomicroscopic examination indicated no structural changes at all visits. There were no significant adverse events reported during the course of the study. CONCLUSION The study confirms that GentlePur™ is an appropriate choice as a preservative for ocular application. The new formulation was safe and comfortable when used four times a day in healthy and dry eye subjects.