SOLACE Trial - A Phase 3 Trial in Subjects With Non-infectious Anterior-uveitis.
Trial ID or NCT#
NCT03131154
Status
NOT RECRUITING
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.
Eligibility Criteria
Ages Eligible for Study: 18 to 85
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
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.
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.
Investigator(s)
View on ClinicalTrials.gov
