Clinical Trial: Phase 3 Study of OTX-101 in the Treatment of Keratoconjunctivitis Sicca
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomized, Multicenter, Double-Masked, Vehicle-Controlled Study of the Safety and Efficacy of OTX-101 in the Treatment of Keratoconjunctivitis Sicca
Brief Summary: 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.
Detailed Summary:
Sponsor: Ocular Technologies SARL
Current Primary Outcome: Tear Production [ Time Frame: 12 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Conjunctival Staining [ Time Frame: 12 weeks ]change from baseline in total conjunctival staining score (lissamine green, modified NEI/FDA scale) at 12 weeks
- Central corneal staining [ Time Frame: 12 weeks ]change from baseline in central corneal staining score (fluorescein, modified NEI/FDA scale) at 12 weeks
- Symptom Score [ Time Frame: 12 weeks ]change from baseline in modified SANDE score at 12 weeks
Original Secondary Outcome: Same as current
Information By: Ocular Technologies SARL
Dates:
Date Received: February 13, 2016
Date Started: February 2016
Date Completion:
Last Updated: February 15, 2017
Last Verified: February 2017