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• W2892874106 abstract "A Phase II/III, randomized, double-masked, vehicle-controlled, dose-ranging study of the safety and efficacy of OTX-101 in the treatment of dry eye disease Joseph Tauber,1 Barry A Schechter,2 Jason Bacharach,3 Melissa M Toyos,4 Robert Smyth-Medina,5 Sidney L Weiss,6 Jodi I Luchs7 1Tauber Eye Center, Kansas City, MO, USA; 2Florida Eye Microsurgical Institute, Boynton Beach, FL, USA; 3North Bay Eye Associates, Petaluma, CA, USA; 4Toyos Clinic, Nashville, TN, USA; 5North Valley Eye Medical Group, Mission Hills, CA, USA; 6i-Novion, Inc, Randolph, NJ, USA; 7South Shore Eye Care, Wantagh, NY, USA Purpose: The aim of this study was to evaluate the safety and efficacy of OTX-101, a clear nanomicellar aqueous solution of cyclosporine, in the treatment of dry eye disease (DED).Patients and methods: This was a 12-week multicenter, randomized, prospective, double-masked, vehicle-controlled, dose-ranging clinical trial. Subjects were adults aged ≥18 years, with a total conjunctival staining score of ≥3 and ≤9, and global DED symptom score ≥40 (0–100 visual analogue scale). Following a 14-day vehicle run-in, subjects were randomized in a 1:1:1 ratio to twice daily treatment with OTX-101 0.09%, OTX-101 0.05%, or vehicle for 84 days. Co-primary efficacy end points were changes, from baseline to Day 84, in the total lissamine green conjunctival staining score in the designated study eye and in the global symptom score (both eyes). Secondary end points included total corneal fluorescein staining score, tear breakup time, and Schirmer’s test score.Results: In total, 455 subjects were randomized. Subjects treated with active drug experienced greater improvement in conjunctival staining than vehicle-treated patients (P" @default.
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• W2892874106 date "2018-10-01" @default.
• W2892874106 modified "2023-09-26" @default.
• W2892874106 title "A Phase II/III, randomized, double-masked, vehicle-controlled, dose-ranging study of the safety and efficacy of OTX-101 in the treatment of dry eye disease" @default.
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• W2892874106 doi "https://doi.org/10.2147/opth.s175065" @default.
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