Miebo for Dry Eye Syndrome

No longer recruiting at 12 trial locations

Overseen By Natasa Orlic-Pleyer

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Bausch & Lomb Incorporated

Must not be taking: Ocular steroids, Dry eye therapy

Disqualifiers: Eye trauma, Blepharitis, Pterygium, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the treatment Miebo™ affects eye measurements and vision accuracy before and after cataract surgery in individuals with dry eye syndrome. The goal is to determine if Miebo™ can improve outcomes for those undergoing routine cataract surgery, which involves replacing the cloudy lens of the eye. Participants must have at least one eye scheduled for cataract surgery and experience symptoms of dry eye, such as a gritty feeling or frequent tearing. As a Phase 4 trial, Miebo™ is already FDA-approved and proven effective, and this research aims to understand how it benefits more patients.

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

The trial requires that you stop using certain eye drops and devices in the study eye within 24 hours before the first visit, and some other ocular therapies within 30 days before the first visit. If you are taking oral medications that cause dry eyes, you need to be on a stable regimen for at least a month before the trial.

What is the safety track record for Miebo™?

Research has shown that Miebo is generally well-tolerated by people with dry eye syndrome. Studies have found that Miebo can help increase tear production, although some patients may notice improvements only after 3-6 months.

The FDA has approved Miebo for treating dry eye disease, indicating it is considered safe. While side effects can occur, they are usually mild, such as temporary eye discomfort or irritation, and serious side effects are rare.

Based on this information, Miebo appears to be a safe option for managing dry eye symptoms. Always consult a healthcare professional about any concerns before joining a trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Miebo™ is unique because it offers a new approach to treating Dry Eye Syndrome by focusing on stabilizing the tear film through its microemulsion formulation. Unlike traditional treatments like artificial tears or anti-inflammatory drops that primarily address symptoms or inflammation, Miebo™ aims to enhance the lipid layer of the tear film, potentially improving eye lubrication and comfort more effectively. Researchers are excited about Miebo™ because its novel mechanism could offer quicker relief and longer-lasting results for those suffering from dry eyes.

What is the effectiveness track record for Miebo in treating Dry Eye Syndrome?

Research shows that Miebo™ effectively treats dry eye syndrome. Studies have found that it helps retain tears on the eye longer, keeping the eyes moist for an extended period. Patients have reported a significant reduction in the frequency and severity of their dry eye symptoms. Relief can occur rapidly, sometimes within just five minutes of using the drops. These findings suggest that Miebo™ can offer meaningful relief for individuals with dry eye syndrome. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals with Dry Eye Syndrome who are preparing for eye surgery. The study aims to include those who need accurate measurements of their eyes (biometry/keratometry) before surgery and want to improve the precision of their vision after the operation.

Inclusion Criteria

Able and willing to follow instructions, including participation in all trial assessments and visits.

Able to provide written voluntary informed consent

In the Investigator's opinion, subject has potential postoperative pinhole Snellen visual acuity of at least 20/200 in both eyes

Exclusion Criteria

I have an irregularly shaped cornea.

History of herpetic keratitis

I have significant eye surface damage or abnormal tissue.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Miebo treatment preoperatively to assess its effect on biometry/keratometry accuracy

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with a focus on refractive accuracy

4-6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Miebo™

Trial Overview

The study is testing Miebo™, a treatment designed to help with Dry Eye Syndrome. It's an open-label Phase 4 trial, meaning everyone knows they're getting Miebo™, and it's being conducted across multiple centers.

How Is the Trial Designed?

Group I: Miebo treatment Experimental Treatment 1 Intervention

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

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11374244/

MEIBO (perfluorohexyloctane): a novel approach to treating ...

In the first study, 60 patients were enroled, and results showed improved tear film break-up time (8.72 ± 4.58 s), Ocular Surface Disease Index (OSDI) (26.37 ± ...

2.

miebo-ecp.com

miebo-ecp.com/siteassets/pdf/opth-and-therapy-reprint-miebo-in-ded-early-symptom-study-results.pdf

Reported Outcomes in Dry Eye Disease

This study found that patients with DED experi- enced significant and meaningful reductions in the severity and frequency of dry eye symptoms within the first ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12282798/

Efficacy and safety of perfluorohexyloctane (PFHO) in patients ...

It has proved to be highly effective in alleviating eye dryness and associated symptoms. While minor side effects are seen in a small subset of ...

4.

ir.bausch.com

ir.bausch.com/press-releases/bausch-lomb-announces-publication-phase-4-data-early-effects-miebor

Bausch + Lomb Announces Publication of Phase 4 Data ...

These patient-reported results show that MIEBO provided relief from dry eye symptoms quickly – in some cases in as little as five minutes after the patient's ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06176651?term=PERFLUOROHEXYLOCTANE&rank=4

Evaluation of Miebo (Perfluorohexyloctane) Eyedrops in ...

Successful tolerability will be quantified by am increase in the total CLDEQ-8 score of 10% or less compared to the baseline CLDEQ-8 score.

6.

va.gov

va.gov/formularyadvisor/DOC_PDF/MON_Perfluorohexyloctane_MIEBO_Ophthalmic_Solution_Monograph.pdf

Perfluorohexyloctane (MIEBO) Ophthalmic Solution

To Increase tear production in those with keratoconjunctivitis sicca (dry eye). •. Can take 3-6 months to notice increase in tear production or symptom ...

7.

allumaco.com

allumaco.com/hubfs/2024%20Prior%20Authorization%20Policies/O/Ophthalmology%20-%20Dry%20Eye%20Disease%20-%20Miebo%20PA%20Policy.pdf

Dry Eye Disease – Miebo Prior Authorization Policy

Dry Eye Disease. Approve for 1 year if the patient is ≥ 18 years of age. Note: Examples of dry eye disease include dry eye syndrome and ...

8.

healio.com

healio.com/clinical-guidance/drugs/miebo

Miebo: Uses, Side Effects & Dosage

Find clinical guidance on Miebo, including indications, dosing, safety, side effects and evidence-based insights for healthcare professionals.

9.

static.cigna.com

static.cigna.com/assets/chcp/pdf/coveragePolicies/cnf/cnf_810_coveragepositioncriteria_ophthalmic_for_dry_eye_disease_miebo_pa.pdf

Dry Eye Disease – Miebo Prior Authorization Policy

Approve for 1 year if the patient is ≥ 18 years of age. Note: Examples of dry eye disease include dry eye syndrome and keratoconjunctivitis ...