ClinicalTrials.gg
RecruitingNCT07650708SonoranUpdated Jun 24, 2026

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

A Phase 4 interventional study of Miebo four times per day in Dry Eye Syndrome (DES) and Dry Eye Disease (DED), sponsored by Vance Thompson Vision. Recruiting at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-24.

Sponsored by Vance Thompson Vision · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Started May 2026; still recruiting 6 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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)

02

Conditions studied

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

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03

In context

Dry Eye Syndromes

1,366 studies on the registry are indexed under Dry Eye Syndromes; 207 are open to participants now.

This study's planned enrollment of 100 is above the median of 60 across 1,129 interventional studies indexed under Dry Eye Syndromes.

Browse Dry Eye Syndromes studies →

Lead sponsor

Vance Thompson Vision is the lead sponsor of 20 studies on the registry; 7 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Be at least 18 years of age at the time of consent, able to provide written voluntary , willing to follow instructions and participate in all trial assessments and visits
  2. 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)
  3. No history of refractive surgery including implantable Collamer lens (ICL) or cataract surgery
  4. Total CFS score ≥1 and ≤6 using the National Eye Institute scale at Visit 1 (in at least one eye)
  5. Ocular Surface Disease Index (OSDI) ≥13 and ≤22 at Visit 1

Exclusion criteria

Exclusion Criteria:

  1. Have any 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:

    1. History of eye trauma/surgery within the last 6 months that resulted in corneal scarring
    2. DED secondary to scarring, irradiation, alkali burns, cicatricial pemphigoid, or destruction of conjunctival goblet cells, Stevens-Johnson syndrome, active blepharitis, or lid margin inflammation
    3. Abnormal cornea (e.g., keratoconus or corneal epithelial defect, pterygium, or history of herpetic keratitis)
  2. Use of any of the following ocular therapies in the study eye within 30 days prior to Visit 1: topical ocular treatments, prescription dry eye therapy (including nasal spray), or topical intraocular pressure-lowering medications
  3. Use of any eye drops (prescription or over the counter) in the study eye within 24 hours prior to Visit 1
  4. 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
  5. Had a LipiFlow®, intense pulsed light (IPL) therapy, etc. in the study eye within 3 months prior to Visit 1
  6. 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
  7. 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
  8. Have undergone intraocular surgery or ocular laser surgery in the study eye within 3 months prior to Visit 1
  9. Have ocular allergies that are/expected to be active during the trial period
  10. Have active ocular or systemic infection (bacterial, viral, or fungal), including fever
  11. Have any ocular findings or uncontrolled systemic disease that, in the opinion of the Investigator, will interfere with the trial
  12. Female subjects who are pregnant, nursing, or planning a pregnancy
  13. Female subjects of who are not using an acceptable means of ; acceptable methods of contraception include hormonal (oral, implantable, injectable, or transdermal) contraception; mechanical (spermicide in conjunction with a barrier such as a diaphragm or condom) contraception; intrauterine device; or surgical sterilization of partner. For non-sexually active female subjects, abstinence may be regarded as an adequate method of birth control; however, if the subject becomes sexually active during the trial, she must agree to use adequate birth control as defined above for the remainder of the trial.
  14. Have a known allergy and/or sensitivity or lack of desired efficacy in response to the drug
  15. Are currently enrolled in an investigational drug or device study or had used an investigational drug or device within 30 days prior to Visit 1 -
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    Miebo

    Miebo instilled four times per day to each eye

    Drug: Miebo four times per day

Interventions

  • DrugMiebo four times per day

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

06

What researchers measure

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)

    Time frame: 4 months

07

Study locations

3 of 4 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07650708
Lead sponsor
Vance Thompson Vision
Responsible party
Sponsor
First posted
Jun 16, 2026
Start date
May 5, 2026
Primary completion
Nov 1, 2026 (estimated)
Completion
Dec 1, 2026 (estimated)
Last update
Jun 24, 2026

Study contacts

Kayla Karpuk, OD
Contact
kayla.karpuk@vancethompsonvision.com
605-371-6883

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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