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Miebo for Dry Eye Syndrome

Phase 4
Recruiting
Research Sponsored by Bausch & Lomb Incorporated
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be at least 18 years of age at the time of consent
Be older than 18 years old
Must not have
Be a woman of childbearing potential who is not using an acceptable method of birth control
Have any planned ocular and/or lid surgeries in either eye during the course of the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at month 3 and month 12 visits
Awards & highlights

Summary

This trial aims to study the effects of using Miebo® eye drops on the cells of the inner layer of the cornea in people with dry eye disease. Participants will be randomly assigned to either

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed here, common ones for eye solutions like Miebo® may include temporary discomfort, redness or irritation in the eye. More serious side effects could occur but would be monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am a woman who can have children and am not using birth control.
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I am not planning any eye or eyelid surgeries during the study.
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I have had herpetic keratitis in one or both of my eyes.
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I have not had laser eye surgery in the last 3 months.
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I am not pregnant, nursing, or planning to become pregnant during the study.
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I am a woman who can have children and refuse to take a pregnancy test.
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I have cancer in or around my eye.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at month 3 and month 12 visits
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at month 3 and month 12 visits for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean change from baseline in ECD

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: MieboExperimental Treatment1 Intervention
100% perfluorohexyloctane 4 times daily (QID)
Group II: Saline solutionPlacebo Group1 Intervention
(0.6% sodium chloride solution) 4 times daily (QID)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Miebo
2023
Completed Phase 4
~150

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Who is running the clinical trial?

Bausch & Lomb IncorporatedLead Sponsor
255 Previous Clinical Trials
57,440 Total Patients Enrolled
~133 spots leftby Feb 2026
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