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 ]

Proportion of subjects with a clinically meaningful increase from baseline in Schirmer's test at 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