Clinical Trial: A Phase 3 Study to Evaluate ADX-102 Ophthalmic Solution in Subjects With Non-infectious Anterior-uveitis.

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase 3, Randomized, Double-masked, Vehicle-controlled Trial to Evaluate the Safety and Efficacy of ADX-102 Ophthalmic Solution in Subjects With Non-infectious Anterior-uveitis

Brief Summary: A Phase 3, randomized, double-masked, vehicle-controlled trial to evaluate the safety and efficacy of ADX-102 ophthalmic solution in Subjects with non-infectious anterior-uveitis.

Detailed Summary:
Sponsor: Aldeyra Therapeutics, Inc.

Current Primary Outcome: Efficacy of ADX-102 on anterior chamber cell count using an anterior uveitis grading scale. [ Time Frame: Efficacy assessment period (Day 1 through Day 29) ]

Evaluate the efficacy of ADX-102 Ophthalmic Solution on anterior chamber cell count in subjects with non-infectious anterior uveitis.


Original Primary Outcome: Same as current

Current Secondary Outcome: Efficacy of ADX-102 on anterior chamber flare using an anterior uveitis grading scale. [ Time Frame: Efficacy assessment period (Day 1 through Day 29) ]

Evaluate the signs and symptoms of ADX-102 Ophthalmic Solution on anterior chamber flare in subjects with non-infectious anterior uveitis.


Original Secondary Outcome: Same as current

Information By: Aldeyra Therapeutics, Inc.

Dates:
Date Received: April 4, 2017
Date Started: April 26, 2017
Date Completion: December 2018
Last Updated: May 26, 2017
Last Verified: April 2017