A Randomized, Multicenter, Double-Masked, Vehicle-Controlled, Dose-Ranging Study of the Safety and Efficacy of OTX-101 in the Treatment of Keratoconjunctivitis Sicca

NCT02254265 Phase 2/Phase 3 COMPLETED Results posted

This is a Phase 2/3 study to evaluate the safety and efficacy of 2 different dose concentrations of OTX-101 dosed twice a day in both eyes for 84 days compared to placebo (vehicle) in patients with keratoconjunctivitis sicca (dry eye disease).

Details

Lead sponsor	Sun Pharmaceutical Industries Limited
Phase	Phase 2/Phase 3
Status	COMPLETED
Enrolment	455
Start date	2014-09
Completion	2015-05

Conditions

• Keratoconjunctivitis Sicca
• Dry Eye Disease

Interventions

• OTX-101 0.05%
• OTX-101 0.09%
• Vehicle

Primary outcomes

• Conjunctival Staining — Baseline to 84 days
  Mean change from baseline at day 84 for the lissamine green conjunctival staining score in the designated study eye. The Investigator recorded a score for each area of each eye on a 0 (No punctate stain in zone) to 3 (Densely concentrated micropunctate stain spots) scale
• Global Symptom Score — Baseline to 84 days
  Mean change from baseline at day 84 for the global symptom score. The freuency and severy of dry eye and irritation scores were used to calculate symptom score as follows: Frequency of dry eye/irritation based on a scale of 0 (rarely) to 100 (all the time) Severity of dryness or irritation based on a scale of 0 (very mildly) to 100 (very severe). The global symptom score was calculated as the square root of the frequency score times the severity score

Countries

United States