Miebo for Dry Eye Syndrome

Not currently recruiting at 7 trial locations

Overseen By Daniel Donatello

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Bausch & Lomb Incorporated

Must not be taking: Ocular steroids, Antibiotics, Anti-allergy

Disqualifiers: Ocular surgery, Active infection, 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: 4

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a treatment called Miebo (also known as Perfluorohexyloctane) for individuals with dry eye syndrome who wear contact lenses. Researchers seek to determine if Miebo improves comfort and eye health during contact lens use. The study is recruiting participants who have worn soft contact lenses for at least six hours a day, five days a week, for the past six months. As a Phase 4 trial, Miebo has already received FDA approval and demonstrated effectiveness, and this research aims to understand its benefits for a broader patient population.

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

The trial requires you to stop using certain eye drops and therapies, like artificial tears and prescription dry eye treatments, at least 24 hours before the study starts. Other specific medications, like topical ocular steroids and antibiotics, must be stopped 30 days before the trial.

What is the safety track record for Miebo (perfluorohexyloctane)?

Research shows that Miebo, also known as perfluorohexyloctane, is generally safe for people with dry eye disease. Studies have found it effective in treating the symptoms of this condition. The data reports no major safety issues. Most side effects, if any, have been mild.

Importantly, the FDA has already approved Miebo for treating dry eye disease, indicating thorough safety testing in humans. While monitoring for any new side effects remains important, current evidence supports its safe use. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard of care for dry eye syndrome, which often includes artificial tears and anti-inflammatory eye drops, Miebo uses perfluorohexyloctane as its active ingredient. This is a novel compound that works by providing a stable layer on the eye surface, helping to reduce tear evaporation. Researchers are excited about Miebo because it offers a new mechanism of action that could provide relief for patients who have not responded well to traditional treatments. Additionally, its unique formulation may offer longer-lasting relief, which could improve the quality of life for those suffering from chronic dry eye.

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

Research has shown that Miebo, containing the ingredient perfluorohexyloctane, holds promise for treating dry eye syndrome. Studies have found that it significantly reduces the signs and symptoms of dry eyes, relieving dryness and increasing comfort. Some individuals might experience minor side effects, such as mild eye irritation, but for most, the benefits outweigh these concerns. Overall, previous patients reported meaningful improvements in their dry eye symptoms with Miebo. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who wear soft contact lenses regularly and have had a recent eye exam. They must be willing to follow the study's instructions, including wearing their lenses for at least 6 hours daily during the study. Women of childbearing age must use birth control, as must men with partners of childbearing potential.

Inclusion Criteria

Able to provide written voluntary informed consent and sign the Health Insurance Portability and Accountability Act (HIPAA) form as well as the Experimental Subjects Bill of Rights (for subjects in California)

Subject must have a documented Manifest Refraction by the PI (or sub-investigator at the same site) performed in the past 180 days prior to screening

Currently wearing soft, frequent-replacement lenses bilaterally (daily-disposable, bi-weekly, or monthly lenses that are available in the US), habitually for a minimum of 5 days/week for 6 hours/day over the last 6 months prior to Visit 1 and willing to wear them for at least 6 hours/day every day during the study

Exclusion Criteria

Subjects who are non-contact lens wearers or who have changed contact lens type/brand within the last 6 months

Subjects who do not have a documented Manifest Refraction within 180 days prior to Visit 1 by the Principal Investigator (or sub-investigator at the same site)

Subjects who wear scleral lenses, rigid gas-permeable lenses, hybrid lenses, custom soft contact lenses with a replacement schedule >30 days, or soft contact lenses on an extended-wear basis

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants use Miebo (perfluorohexyloctane ophthalmic solution) while wearing contact lenses

4 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Perfluorohexyloctane

Trial Overview

The trial is testing Perfluorohexyloctane ophthalmic solution (Miebo) in people who wear contact lenses to see if it affects dry eye syndrome while using contacts.

How Is the Trial Designed?

Group I: Miebo (perfluorohexyloctane ophthalmic solution) 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 ...

Ocular AEs were experienced by 9.6% of patients. Eye irritation, conjunctivitis, dry eye, punctate keratitis, blurred vision (mostly mild and transient), ...

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

In randomized controlled trials of per- fluorohexyloctane ophthalmic solution. (PFHO), significant reductions in signs and symptoms of dry eye disease were ...

3.

journals.lww.com

journals.lww.com/md-journal/fulltext/2025/07180/efficacy_and_safety_of_perfluorohexyloctane__pfho_.123.aspx

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

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.

clinicaltrials.gov

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

Evaluation of Miebo (Perfluorohexyloctane) Eyedrops in ...

The primary endpoint is to show that Miebo eye drops are safe to use in contact lens wearers. The secondary endpoint is to show changes in comfort in contact ...

5.

link.springer.com

link.springer.com/article/10.1007/s40123-025-01097-z

Early Effects of Perfluorohexyloctane Ophthalmic Solution ...

This study found that patients with DED experienced significant and meaningful reductions in the severity and frequency of dry eye symptoms ...

6.

va.gov

va.gov/formularyadvisor/DOC_PDF/MON_Perfluorohexyloctane_MIEBO_Ophthalmic_Solution_Monograph.pdf

Perfluorohexyloctane (MIEBO) Ophthalmic Solution

Key inclusions: ≥18 years of age, self-reported history of DED in both eyes for ≥ 6 months. • Tear film break-up time (TFBUT) ≤ 5 seconds (> 8-10 seconds is ...

7.

miebo.com

miebo.com/

MIEBO® (perfluorohexyloctane ophthalmic solution) Dry Eye ...

MIEBO ® (perfluorohexyloctane ophthalmic solution) is used to treat the signs and symptoms of dry eye disease. IMPORTANT SAFETY INFORMATION. Remove contact ...

8.

static.cigna.com

static.cigna.com/assets/chcp/pdf/coveragePolicies/pharmacy/ip_0583_coveragepositioncriteria_perfluorohexyloctane.pdf

Dry Eye Disease – Miebo For Individual and Family Plans

Miebo for any other use is considered not medically necessary. Criteria will be updated as new published data are available. References. 1. Miebo™ ophthalmic ...

9.

reference.medscape.com

reference.medscape.com/drug/miebo-perfluorohexyloctane-ophthalmic-4000338

Miebo - perfluorohexyloctane ophthalmic (Rx)

Indicated for treatment of signs and symptoms of dry eye disease (DED). Instill 1 drop into affected eye(s).