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.
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Aldeyra Therapeutics, Inc.
- Enrollment
- 123
- Locations
- 26
- Primary Endpoint
- Number of Subjects Who Meet Time to Clearance of Anterior Chamber Cells
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- 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.
Arms & Interventions
ADX-102 Ophthalmic Solution (0.5%)
Intervention: ADX-102 Ophthalmic Solution (0.5%) (Drug)
Vehicle of ADX-102 Ophthalmic Solution
Intervention: Vehicle of ADX-102 Ophthalmic Solution (Drug)
Outcomes
Primary Outcomes
Number of Subjects Who Meet Time to Clearance of Anterior Chamber Cells
Time Frame: The efficacy assessment period was 4 weeks; baseline was defined as Day 1.
Time to clearance of anterior chamber cells was defined as the time from initiation of study drug to when a cell count of 0 was achieved and maintained (without cell count increases to \>0) to Week 4 and without rescue or discontinuation due to rescue prior to Week 4. Anterior chamber cell count is the number of cells visible within the anterior chamber of the eye, measured using a slit lamp and following SUN (Standardization of Uveitis Nomenclature) where a cell count \<1 is Grade 0 (absent) and a cell count of \>50 is Grade 4+ (severe).
Secondary Outcomes
No secondary outcomes reported