Miebo for Dry Eye Syndrome

Recruiting at 11 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Bausch & Lomb Incorporated

Prior Safety Data

Trial Summary

What is the purpose of this trial?

A Randomized, Multicenter, Double-Masked, Saline-Controlled Trial to Evaluate Corneal Endothelial Cell Density in Subjects With Dry Eye Disease Administering Miebo® (Perfluorohexyloctane Ophthalmic Solution) for 12 Months

Eligibility Criteria

This trial is for individuals with Dry Eye Disease (DED). Specific eligibility criteria are not provided, but typically participants must have a confirmed diagnosis of DED and meet certain health standards as determined by the study.

Inclusion Criteria

If a contact lens wearer, be willing to discontinue contact lens use during and for 30 minutes following instillation of investigational drug and during study visits

I have had dry eye disease in both eyes for at least 6 months.

Have a total corneal fluorescein staining score (tCFS) score >2 in both eyes

Exclusion Criteria

I have not had eye surgery or severe eye trauma in the last 3 months.

I am a woman who can have children and am not using birth control.

Have any clinically significant ocular surface slit lamp findings and/or in the opinion of the Investigator have any findings that may interfere with trial parameters in either eye

Treatment Details

Interventions

• Miebo (Other)

Trial Overview The trial is testing Miebo®, an ophthalmic solution, against saline (a saltwater solution) to see its effects on corneal endothelial cell density over 12 months. It's randomized and double-masked, meaning neither the researchers nor participants know who gets which treatment.

Participant Groups

Group I: Miebo Experimental Treatment 1 Intervention

100% perfluorohexyloctane 4 times daily (QID)

Group II: Saline solution Placebo Group 1 Intervention

(0.6% sodium chloride solution) 4 times daily (QID)

Who Is Running the Clinical Trial?

Bausch & Lomb Incorporated

Lead Sponsor

Trials

263

Recruited

59,400+

Dr. Christina Ackermann

Bausch & Lomb Incorporated

Chief Medical Officer since 2023

MD from Harvard Medical School

Brent Saunders

Bausch & Lomb Incorporated

Chief Executive Officer since 2023

BA from the University of Pittsburgh, JD and MBA from Temple University