A Multicenter, Open-Label Study to Evaluate Perioperative Treatment of Dry Eye With Miebo® in Subjects Undergoing LASIK

ConditionsDry Eye Syndrome (DES)Dry Eye Disease (DED)

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

Miebo four times per day
Drug
Single arm study where subjects dose with Miebo four times per day for one month before LASIK and for 1.5 months after LASIK

Treatment groups

100 Participants

are divided into 1 treatment group

Group A: MieboActive comparator 1 intervention

Trial outcomes

Primary outcomes

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

Visual analog scole with a minimum score of 0 (lowest rating) and maximum score of 100 (highest rating)

Time frame

4 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vance Thompson Vision

Lead sponsor

Bausch & Lomb Incorporated

Collaborator

Source ClinicalTrials.gov

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