A Multicenter, Open-Label Study to Evaluate Perioperative Treatment of Dry Eye With Miebo® in Subjects Undergoing LASIK
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorVance Thompson Vision
About this trial
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)
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
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
Trial design
Treatments tested in this trial
- Miebo four times per day
Treatment groups
100 Participants
are divided into 1 treatment groupSponsors and collaborators
Vance Thompson Vision
Lead sponsor
Bausch & Lomb Incorporated
Collaborator
Source ClinicalTrials.gov