Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Brimonidine 0.025% preservative-free formulation · 1 trial · 1 indication
Ocular redness score evaluated by the investigator from 5 minutes to 240 minutes after investigational drug instillation (0-4 unit scale, where 0 = None and 4 = Extremely severe).
| Arm | Type | Description |
|---|---|---|
| Brimonidine tartrate preservation-free | EXPERIMENTAL | Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulation |
| Lumify® | ACTIVE_COMPARATOR | Lumify® (brimonidine tartrate ophthalmic solution 0.025%) |
| Name | Type | Description |
|---|---|---|
| Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulation | DRUG | Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulation. Participants will instill 1 drop of the assigned investigational drug in each eye 4 times a day approximately 4 hours apart for up to 4 consecutive weeks. |
| Lumify® (brimonidine tartrate ophthalmic solution 0.025%) | DRUG | Lumify® (brimonidine tartrate ophthalmic solution 0.025%). Participants will instill 1 drop of the assigned investigational drug in each eye 4 times a day approximately 4 hours apart for up to 4 consecutive weeks. |
Inclusion Criteria: 1. Be at least 18 years of age at the time of Informed Consent signing of either gender and any race or ethnicity; 2. Provide written informed consent and sign the HIPAA form; 3. Be willing and able to follow all instructions and attend all study visits; 4. Have a history of vas...