SOLACE Trial - A Phase 3 Trial in Subjects With Non-infectious Anterior-uveitis.

• Status: Completed
• Trial end date: 2019-04-26
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aldeyra Therapeutics, Inc.
• Treatments: Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Male or female subjects aged ≥ 18 years and ≤ 85 years.

• Subjects with acute non-infectious anterior uveitis with onset of symptoms within the previous 2 weeks.

• Best corrected visual acuity (BCVA) better than or equal to 35 letters in the study eye and 65 letters in the non-study eye using ETDRS testing.

Exclusion Criteria:

• Have severe/serious ocular pathology in the study eye(s) which may preclude study completion, in the judgement of the Investigator.

• Active intermediate or posterior uveitis in the study eye(s).

• Previous anterior uveitis episode in the study eye ≤ 4 weeks prior to screening.

• Have participated in another investigational device or drug study within 30 days prior to screening.

• Participation in a prior ADX-102 study.