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Minas T Coroneo, Pasquale Aragona, Jose Benitez-del-Castillo, Jacqueline Tan, Evelien Vandewalle, Algis J Vingrys, Haixia Liu, Peter A Simmons, Joseph Glennon Vehige, Ru Chen; A Controlled 3-Month Clinical Study to Evaluate the Safety and Efficacy of an Investigational Eye Drop Formulation in Subjects with Dry Eye Disease. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):4459.
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Artificial tears are commonly used to relieve symptoms of dry eye. The purpose of this investigation was to compare the efficacy and safety of a new artificial tear that combines two commonly used polymers, Carboxymethylcellulose (CMC) and hyaluronic acid (HA), to a standard formulation of CMC alone.
A new preservative-free artificial tear (CMC-HA) was compared with an existing artificial tear (CMC, Optive UD, Allergan). Subjects with mild to moderate signs and symptoms of dry eye were enrolled in this double-masked, randomized multi-center trial, and dosed at least 2X a day for 90 days, with follow-up visits at Days 7, 30, 60, and 90. The Ocular Surface Disease Index (OSDI) was the primary outcome measure. Secondary outcome measures were tear breakup time (TBUT), ocular surface staining, Schirmer test and visual analog (VAS) scales to measure dry eye symptom severity and formulation acceptability. Safety measures included adverse events, biomicroscopy and visual acuity.
460 subjects were enrolled across 45 sites (38 in Europe and 7 in Australia). The mean +/- s.d. change from baseline in OSDI score at the primary timepoint, day 90 (per-protocol population, n=364), was -16.9 +/- 17.5 for CMC-HA and -16.0 +/- 16.1 for CMC. CMC-HA was non-inferior to CMC based upon a confidence interval method. Both treatments produced statistically significant improvements (paired t-tests, p<0.001) from baseline at all follow up visits for OSDI, ocular surface staining, TBUT, and symptom VAS scores, with minimal differences between groups. Acceptability scores for eye drop experience were high (>70 on a 0-100 scale at day 90) and comparable between groups. The safety profiles of the 2 groups were similar, with approximately 10% of subjects in each group reporting treatment-related adverse events of generally mild to moderate severity. The majority of events are typical in dry eye patients, including eye irritation, conjunctival hyperemia, foreign body sensation, erythema of the eyelid, blepharitis, eye pain, and blurred vision.
The new CMC-HA formulation was shown to be effective, safe and well-tolerated during the study. These data are supportive of the implementation of this formula for the management of dry eye patients.
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