Miebo for Dry Eye Syndrome

Recruiting at 11 trial locations

Overseen By Margaret Swartzenberg

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Bausch & Lomb Incorporated

Disqualifiers: Ocular malignancy, Herpetic keratitis, Pregnancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

216 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

How does the treatment Miebo differ from other treatments for dry eye syndrome?

Miebo is unique because it uses thermoelectric warming therapy to treat dry eye syndrome by improving the function of the meibomian glands, which are crucial for maintaining a healthy tear film. This approach is different from other treatments that may focus on increasing tear production or reducing inflammation. ^{1 2 3 4 5}

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Miebo® (Perfluorohexyloctane Ophthalmic Solution) or saline solution 4 times daily for 12 months

12 months

Monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Treatment Details

Interventions

• Miebo

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

Findings from Research

In a phase 3 study involving 599 adults with dry eye disease, NOV03 (perfluorohexyloctane) significantly improved eye dryness and corneal staining compared to saline, showing clinically meaningful benefits after 8 weeks of treatment.

The treatment was well tolerated, with most side effects being mild and no serious adverse events reported, indicating a favorable safety profile for NOV03 in managing dry eye disease associated with meibomian gland dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

NOV03 for Dry Eye Disease Associated with Meibomian Gland Dysfunction: Results of the Randomized Phase 3 GOBI Study. Tauber, J., Berdy, GJ., Wirta, DL., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effect of Thermoelectric Warming Therapy for the Treatment of Meibomian Gland Dysfunction. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Effect of a Novel Thermostatic Device on Meibomian Gland Dysfunction: A Randomized Controlled Trial in Chinese Patients. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Correlations among symptoms, signs, and clinical tests in evaporative-type dry eye disease caused by Meibomian gland dysfunction (MGD). [2022]

4. United States pubmed.ncbi.nlm.nih.gov

New agents for treating dry eye syndrome. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

NOV03 for Dry Eye Disease Associated with Meibomian Gland Dysfunction: Results of the Randomized Phase 3 GOBI Study. [2023]