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COMPLETEDPHASE4

A Study to Evaluate Early Treatment Outcomes With Miebo™ in Subjects With Dry Eye Disease

An Open-Label, Multicenter, Phase 4 Study to Evaluate Early Treatment Outcomes With Miebo™ in Subjects With Dry Eye Disease

NCT06309953•Bausch & Lomb Incorporated

View on ClinicalTrials.gov

Summary

An Open-Label, Multicenter, Phase 4 Study to Evaluate Early Treatment Outcomes With Miebo™ in Subjects With Dry Eye Disease

Detailed Description

The primary objective of this study is to evaluate early outcomes with Miebo treatment in subjects with Dry Eye Disease (DED)

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. At least 18 years of age at the time of consent
•2. Able to provide written voluntary informed consent
•1. Subject-reported history of DED in at least 1 eye for at least 6 months prior to Visit 1
•2. Tear-film break-up time ≤5 seconds at Visit 1
•3. Total corneal fluorescein staining score ≥4 and ≤11 (ie, sum of inferior, superior, central, nasal, and temporal) according to the National Eye Institute scale at Visit 1
•4. Total meibomian gland dysfunction score ≥3 (range, 0-15)
•5. Unanesthetized Schirmer's test I score ≥5 mm
•4. Ocular Surface Disease Index (OSDI) ≥25 at Visit 1
•5. Able and willing to follow instructions, including participation in all trial assessments and visits.

Exclusion Criteria

•1. Had received Miebo as a prescription or as a study treatment in previous Miebo clinical studies
•2. Have any clinically significant ocular surface slit lamp findings at Visit 1 and/or, in the opinion of the Investigator, have any findings that could interfere with trial parameters, including:
•1. History of eye trauma
•2. History of Stevens-Johnson syndrome
•3. Active blepharitis or lid margin inflammation
•4. DED secondary to scarring, irradiation, alkali burns, cicatricial pemphigoid, or destruction of conjunctival goblet cells (as with vitamin A deficiency)
•5. Abnormal lid anatomy causing incomplete eyelid closure
•6. Abnormal cornea shape (keratoconus)
•7. Corneal epithelial defect or significant confluent or filaments
•8. History of herpetic keratitis
+18 more criteria

Locations (7)

Site 207

Birmingham, Alabama, United States

Site 205

Petaluma, California, United States

Site 203

Pittsburg, Kansas, United States

Site 204

Stillwater, Minnesota, United States

Site 202

Kansas City, Missouri, United States

Site 201

Brecksville, Ohio, United States

Site 206

Westlake, Ohio, United States

Key Dates

Start Date

February 28, 2024

Primary Completion Date

June 17, 2024

Completion Date

June 17, 2024

Last Updated

October 21, 2025

Enrollment

ACTUAL participants

Conditions

Dry Eye

Interventions

Miebo

DRUG

A Non-interventional Study to Evaluate the Anti-inflammatory Effects and the Clinical Efficacy of Topical Water Free Cyclosporin 0.1% Eye Drops in Patients With Dry Eye Disease and Associated Ocular Surface Inflammation Non-responding to Artificial Tears: the FOCUS Study

NCT07463950

Dry Eye Disease (DED)

View study

RECRUITING

A Study on the Correlation Between Tear Iron Levels and the Severity of Dry Eye Disease.

NCT07363824

Dry Eye DiseaseIron

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 21, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study to Evaluate Early Treatment Outcomes With Miebo™ in Subjects With Dry Eye Disease

Inclusion Criteria

Exclusion Criteria

A Non-interventional Study to Evaluate the Anti-inflammatory Effects and the Clinical Efficacy of Topical Water Free Cyclosporin 0.1% Eye Drops in Patients With Dry Eye Disease and Associated Ocular Surface Inflammation Non-responding to Artificial Tears: the FOCUS Study

A Study on the Correlation Between Tear Iron Levels and the Severity of Dry Eye Disease.

Supplementary Kelulut Honey Therapy in Juvenile Open-Angle Glaucoma: Effects on IL-6, RNFL and Dry Eye

Preliminary Clinical Study of the Effectiveness and Safety of Ocular Surface Microbiota Transplantation in the Treatment of Dry Eye Disease

Autologous Serum Eye Drops in Dry Eye Syndrome

Assessment of CataClear, Tear Film Stability, Tear Volume, and Dry Eye Symptoms Using Stem Cells Fortified Eye Drops