BL1107 Response and Intensity Guided Dosing for Hyperemia Resolution Trial

ConditionDry Eye Disease

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorBausch & Lomb Incorporated

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Documented diagnosis of dry eye disease

Conjunctival hyperemia in both eyes, without clinical signs of infection or allergic conjunctivitis

Disqualifiers

Any active ocular disease

Anticipated wearing of contact lenses during study

Trial design

Design model

Sequential

Treatments tested in this trial

BL1107
Drug
BL1107 topical ocular solution

Treatment groups

20 Participants

are divided into 1 treatment group

Group A: BL1107 is sterile ophthalmic solution to be administered at varying concentrationsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Primary Part 1: Proportion of participants with complete resolution in conjunctival hyperemia at 30 minutes, in each evaluated concentration of BL1107.

Time frame

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

Time frame

Assessed at 8 hours

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bausch & Lomb Incorporated

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: