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

NCT07650708 | Recruiting Phase 4 FDA Drug

• 1 other identifier: BL-RX01-SONORAN-1401
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

Brief 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)

Conditions

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

Outcome Measures

Primary Outcomes (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

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

  4 months

Study Arms (1)

Miebo

ACTIVE COMPARATOR

Miebo instilled four times per day to each eye

Drug: Miebo four times per day

Interventions

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

Miebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• Had received or removed a permanent punctum plug in the study eye within 1 month (3 months for dissolvable punctum plugs) prior to Visit 1
• Have worn soft contact lenses within either 3 days prior to the study or rigid gas-permeable contact lenses for 1 month prior to Visit 1 or any planned wear during the study
• Have undergone intraocular surgery or ocular laser surgery in the study eye within 3 months prior to Visit 1
• Have ocular allergies that are/expected to be active during the trial period
• Have active ocular or systemic infection (bacterial, viral, or fungal), including fever
• Have any ocular findings or uncontrolled systemic disease that, in the opinion of the Investigator, will interfere with the trial
• Female subjects who are pregnant, nursing, or planning a pregnancy

Sponsors & Collaborators

• Vance Thompson Vision: lead
• Bausch & Lomb Incorporated: collaborator

Study Sites (4)

Vance Thompson Vision- Bozeman

Bozeman, Montana, 59718, United States

RECRUITING

Vance Thompson Vision- Omaha

Omaha, Nebraska, 68137, United States

NOT YET RECRUITING

Vance Thompson Vision- Fargo

Fargo, North Dakota, 58078, United States

RECRUITING

Vance Thompson Vision- Sioux Falls

Sioux Falls, South Dakota, 57108, United States

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Central Study Contacts

Kayla Karpuk, OD

CONTACT

605-371-6883; kayla.karpuk@vancethompsonvision.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 16, 2026
• Study Start: May 5, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)