Miebo for Dry Eye Syndrome

Not currently recruiting at 12 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new eye treatment called Miebo to evaluate its effects on people with dry eye syndrome, a condition where eyes don't produce enough tears or tears evaporate too quickly. Participants will use either Miebo or a saline solution to compare safety and impact on eye health over a year. The trial suits those who have experienced dry eyes in both eyes for over six months and are willing to stop using contact lenses during treatment. As a Phase 4 trial, Miebo has already received FDA approval and proven effective, and this research aims to understand its benefits for more patients.

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.

What is the safety track record for Miebo?

Research has shown that Miebo is generally safe for patients. In earlier studies, some individuals experienced mild side effects, such as temporary eye irritation. Notably, the FDA has already approved Miebo for treating dry eye disease, indicating a strong safety record. While no treatment is entirely without risk, Miebo's approval and past research suggest it is safe for most people. It is important to consult a healthcare provider about potential risks before starting any new treatment. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike other treatments for dry eye syndrome, Miebo uses 100% perfluorohexyloctane, a unique ingredient that acts as a tear film stabilizer. Most current treatments, like artificial tears or anti-inflammatory drops, focus on providing temporary relief or reducing inflammation. Miebo, however, targets the tear film layer directly, potentially offering more lasting relief for dry eye symptoms. This novel approach has researchers excited about its potential to improve comfort and eye health for patients more effectively than existing options.

What is the effectiveness track record for Miebo in treating dry eye syndrome?

Studies have shown that Miebo, a type of eye drop, effectively treats dry eye syndrome. One study found that patients experienced improved tear stability, with tear breakup time increasing to about 8.72 seconds. Additionally, patients reported noticeable reductions in the severity and frequency of dry eye symptoms. In some cases, relief from symptoms occurred as quickly as five minutes after using Miebo. These findings suggest that Miebo can provide quick and significant relief for people with dry eye disease. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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

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

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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. 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 ...

4. 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.

5. optometrytimes.com optometrytimes.com/view/bausch-lomb-publishes-study-results-on-early-patient-reported-outcomes-with-miebo-in-patients-with-ded

Bausch + Lomb publishes study results on early patient- ... Patients reported that Miebo significantly reduced overall symptoms severity at the primary endpoint of change from baseline in the severity ...

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. miebo-ecp.com miebo-ecp.com/

MIEBO® (perfluorohexyloctane ophthalmic solution) MIEBO ® (perfluorohexyloctane ophthalmic solution) is indicated for the treatment of the signs and symptoms of dry eye disease. IMPORTANT SAFETY INFORMATION.