Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03131154 | SOLACE Trial - A Phase 3 Trial in Subjects With Non-infectious Anterior-uveitis. | PHASE3 | COMPLETED | 123 | — | — | Apr 26, 2017 | Apr 26, 2019 | Feb 10, 2025 | 27 | United States |
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).
| Arm | Type | Description |
|---|---|---|
| ADX-102 Ophthalmic Solution (0.5%) | EXPERIMENTAL | - |
| Vehicle of ADX-102 Ophthalmic Solution | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| ADX-102 Ophthalmic Solution (0.5%) | DRUG | ADX-102 Ophthalmic Solution (0.5%) administered for approximately four weeks. |
| Vehicle of ADX-102 Ophthalmic Solution | DRUG | Vehicle of ADX-102 Ophthalmic Solution administered for approximately four weeks. |
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...