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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03879863 | The RENEW Trial: A Multi-Center, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Adaptive Phase 3 Clinical Trial to Assess the Safety and Efficacy of Subjects With Dry Eye Disease | PHASE3 | COMPLETED | 422 | — | — | Apr 16, 2019 | Oct 4, 2019 | Jan 23, 2025 | 1 | United States |
Change from baseline comparison of reproxalap to vehicle for subject-reported ocular dryness score VAS (0 = no discomfort - 100 = maximal discomfort), where a higher score means a worse outcome. The intervention was administered bilaterally. The least squares mean (standard error) was derived from mixed model repeated measures for change from baseline calculated using baseline score, treatment arm, visit, and the interaction of treatment arm and visit as fixed effects.
Change from baseline comparison of reproxalap to vehicle for fluorescein staining of the nasal region (0 = none - 4 = severe), where a higher score means a worse outcome. The intervention was administered bilaterally. The least squares mean (standard error) was derived from mixed model repeated measures for change from baseline calculated using baseline fluorescein nasal score, treatment arm, visit, and the interaction of treatment arm and visit as fixed effects.
| Arm | Type | Description |
|---|---|---|
| Reproxalap Ophthalmic Solution (0.25%) QID | EXPERIMENTAL | - |
| Vehicle Ophthalmic Solution QID | PLACEBO_COMPARATOR | - |
| Reproxalap Ophthalmic Solution (0.25%) QID to BID | EXPERIMENTAL | - |
| Vehicle Ophthalmic Solution QID to BID | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Reproxalap Ophthalmic Solution (0.25%) QID | DRUG | Reproxalap Ophthalmic Solution (0.25%) administered QID for twelve weeks |
| Vehicle Ophthalmic Solution QID | DRUG | Vehicle Ophthalmic Solution administered QID for twelve weeks |
| Reproxalap Ophthalmic Solution (0.25%) QID to BID | DRUG | Reproxalap Ophthalmic Solution (0.25%) administered QID for four weeks, followed by BID administration for eight weeks |
| Vehicle Ophthalmic Solution QID to BID | DRUG | Vehicle Ophthalmic Solution administered QID for four weeks, followed by BID administration for eight weeks |
Inclusion Criteria: * Be at least 18 years of age of either gender and any race; * Have a reported history of dry eye for at least 6 months prior to Visit 1; * Have a history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1 Exclusion Criteria: * Have any clinicall...