Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Reproxalap Ophthalmic Solution (0.25%) QID to BID
Reproxalap QID to · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| Reproxalap (0.25% Novel Formulation) QID to BID | EXPERIMENTAL | - |
| Vehicle Ophthalmic Solution QID to BID | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Reproxalap Ophthalmic Solution (0.25% Novel Formulation) QID to BID | DRUG | Reproxalap Opthalmic Solution (0.25% Novel Formulation) administered QID for four weeks, followed by BID administration for eight weeks |
| Vehicle Ophthalmic Solution (0.25% Novel Formulation) 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...