Miebo for Dry Eye Syndrome
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.12345Why 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.46789
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants use Miebo (perfluorohexyloctane ophthalmic solution) while wearing contact lenses
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Perfluorohexyloctane
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bausch & Lomb Incorporated
Lead Sponsor
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