A Multicenter, Open-Label Study to Evaluate Perioperative Treatment of Dry Eye With Miebo® in Sub… (NCT07650708) | Clinical Trial Compass
RecruitingPhase 4
A Multicenter, Open-Label Study to Evaluate Perioperative Treatment of Dry Eye With Miebo® in Subjects Undergoing LASIK
United States100 participantsStarted 2026-05-05
Plain-language summary
Compare eye dryness following laser-assisted in situ keratomileusis (LASIK) surgery to eye dryness prior to receiving perioperative Miebo in patients with dry eye disease (DED)
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Be at least 18 years of age at the time of consent, able to provide written voluntary informed consent, willing to follow instructions and participate in all trial assessments and visits
. Be a candidate for routine, uncomplicated bilateral LASIK surgery (for spherical equivalent \[≤-8.00D\] myopia or myopic astigmatism correction, not combined with any other procedure; monovision myopic targets are allowed, however the myopic target eye will be the non-study \[fellow\] eye)
. No history of refractive surgery including implantable Collamer lens (ICL) or cataract surgery
. Total CFS score ≥1 and ≤6 using the National Eye Institute scale at Visit 1 (in at least one eye)
. Ocular Surface Disease Index (OSDI) ≥13 and ≤22 at Visit 1
Exclusion criteria
. Have any clinically significant ocular surface slit-lamp findings in the study eye that, in the opinion of the Investigator, could interfere with outcomes of a routine, uncomplicated LASIK surgery, including but not limited to:
. History of eye trauma/surgery within the last 6 months that resulted in corneal scarring
. DED secondary to scarring, irradiation, alkali burns, cicatricial pemphigoid, or destruction of conjunctival goblet cells, Stevens-Johnson syndrome, active blepharitis, or lid margin inflammation
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since I already have dry eye disease and I'm considering LASIK, would joining this trial mean my dry eye symptoms before and after surgery would be closely tracked using a standardized scale, and how might that monitoring benefit my care compared to standard post-LASIK follow-up?
2Miebo is described here as a 'perioperative' treatment, meaning it's used around the time of surgery — can you explain exactly when I would start and stop taking it, and whether that timing changes any risks for someone with my level of dry eye disease?
3This is a Phase 4 trial, which typically means the drug is already approved — does that mean there's more known about Miebo's safety profile compared to earlier-phase studies, and what does the existing evidence say about how well it works for post-LASIK dryness specifically?
4Given that LASIK is known to sometimes worsen dry eye symptoms at least temporarily, would you recommend I try to get my dry eye disease better controlled with standard treatments before even considering surgery, versus enrolling in a trial like this one?
5Since the trial is actively recruiting right now, what would participation actually look like for me in terms of the number of visits, measurements, and how long I'd be followed after surgery — and is that realistic given my schedule and where I live?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Compare eye dryness following laser-assisted in situ keratomileusis (LASIK) surgery to eye dryness prior to receiving perioperative Miebo in patients with dry eye disease (DED) as measured by visual analog scale (VAS) eye dryness score
. Abnormal cornea (e.g., keratoconus or corneal epithelial defect, pterygium, or history of herpetic keratitis)
. Use of any of the following ocular therapies in the study eye within 30 days prior to Visit 1: topical ocular steroid treatments, prescription dry eye therapy (including nasal spray), or topical intraocular pressure-lowering medications
. Use of any eye drops (prescription or over the counter) in the study eye within 24 hours prior to Visit 1
. Use of any oral medications known to cause ocular drying (e.g., antihistamines, antidepressants, etc.) on a non-stable regimen within 1 month prior to Visit 1 or is expected to be unstable during the trial
. Had a LipiFlow®, intense pulsed light (IPL) therapy, etc. in the study eye within 3 months prior to Visit 1