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

NCT02688556 Phase 3 COMPLETED Results posted

This is a randomized, double-masked, vehicle-controlled study of the safety and efficacy of OTX-101 (0.09% cyclosporine nanomicellar solution) in the treatment of keratoconjunctivitis sicca to be conducted at approximately 50 sites.

Details

Lead sponsor	Sun Pharmaceutical Industries Limited
Phase	Phase 3
Status	COMPLETED
Enrolment	745
Start date	2016-02
Completion	2016-12

Conditions

• Keratoconjunctivitis Sicca

Interventions

• cyclosporine
• vehicle of OTX-101

Primary outcomes

• Tear Production — Baseline and 12 weeks
  Percentage of Eyes with Increase from Baseline of ≥ 10 mm in Schirmer's Test Score

Countries

United States