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

Not Recruiting

Trial ID: NCT03131154

Purpose

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.

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.

Stanford Investigator(s)

Diana Do
Diana Do

Professor of Ophthalmology

Eligibility

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.

Intervention(s):

drug: ADX-102 Ophthalmic Solution (0.5%)

drug: Vehicle of ADX-102 Ophthalmic Solution

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305