Dry Eye Disease
Conditions
Brief summary
Trial RX01-BL1107-1202 is designed to identify the lowest effective concentration of BL1107 required for complete resolution of conjunctival hyperemia in participants with DED. Participants will be masked to concentration of BL1107 received.
Interventions
BL1107 topical ocular solution
Sponsors
Study design
Eligibility
Inclusion criteria
* Documented diagnosis of dry eye disease * Conjunctival hyperemia in both eyes, without clinical signs of infection or allergic conjunctivitis
Exclusion criteria
* Any active ocular disease * Anticipated wearing of contact lenses during study Additional criteria per protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Part 1: Proportion of participants with complete resolution in conjunctival hyperemia at 30 minutes, in each evaluated concentration of BL1107. | Assessed at 30 minutes |
| Primary Part 2: Proportion of participants with complete resolution in conjunctival hyperemia at 8 hours, in each evaluated concentration of BL1107 | Assessed at 8 hours |