SOLACE Trial - A Phase 3 Trial in Subjects With Non-infectious Anterior-uveitis.
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.
Condition
- Non-infectious Anterior Uveitis
Eligibility
- Eligible Ages
- Between 18 Years and 85 Years
- Eligible Genders
- 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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental ADX-102 Ophthalmic Solution (0.5%) |
|
|
Placebo Comparator Vehicle of ADX-102 Ophthalmic Solution |
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More Details
- Status
- Completed
- Sponsor
- Aldeyra Therapeutics, Inc.