BL1107 Response and Intensity Guided Dosing for Hyperemia Resolution Trial

NCT07778888 — Phase 2, Not yet recruiting, 20 participants, Bausch & Lomb Incorporated

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Phase 2a Masked Trial to Identify the Lowest Effective Concentration of BL1107 for Conjunctival Hyperemia in Patients With Dry Eye Disease

Registry	NCT07778888, acronym BRIGHT
Status	Not yet recruiting
Phase	Phase 2
Study type	Interventional; na, sequential, masking: none, treatment
Enrollment	20 (Estimated)
Sponsor	Bausch & Lomb Incorporated (Industry)
Conditions	Dry Eye Disease
Interventions	BL1107 (Drug)
Dates	start 2026-10-01 (estimated), primary completion 2027-02-01 (estimated), completion 2027-02-01 (estimated), first posted 2026-08-21, last updated 2026-08-21

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
BL1107 is sterile ophthalmic solution to be administered at varying concentrations	Experimental	Drug: BL1107

BL1107 (Drug): BL1107 topical ocular solution

+Outcome measures

Primary outcomes

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]

+Eligibility

Sex: All, ages: 18 Years to any

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