Phase 3
N=123
SOLACE Trial - A Phase 3 Trial in Subjects With Non-infectious Anterior-uveitis.
Non-infectious Anterior Uveitis
Bottom Line
View on ClinicalTrials.gov: NCT03131154 ↗Enrolled (actual)
123
Serious AEs
2.4%
Results posted
Feb 2025
Primary outcome: Primary: Number of Subjects Who Meet Time to Clearance of Anterior Chamber Cells — 25; 24 Subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ADX-102 Ophthalmic Solution (0.5%) (Drug); Vehicle of ADX-102 Ophthalmic Solution (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Aldeyra Therapeutics, Inc.
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Who Meet Time to Clearance of Anterior Chamber Cells |
25; 24 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT03131154). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.