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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 4INTERVENTIONAL

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

A Multicenter, Open-Label Study to Evaluate Perioperative Treatment of Dry Eye With Miebo® in Subjects Undergoing LASIK (NCT07650708) is a Phase 4 interventional studying Dry Eye Syndrome (DES) and Dry Eye Disease (DED), sponsored by Vance Thompson Vision. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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)

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 100 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Dry Eye Syndrome (DES) subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Be at least 18 years of age at the time of consent, able to provide written voluntary willing to sign a consent form, 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 Who Should NOT Join This Trial: 1. 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: 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 steroid 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. 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 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: 1. 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: 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 steroid 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 childbearing potential who are not using an acceptable means of birth control; 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 investigational 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 -

Treatments Being Tested

DRUG

Miebo 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

Locations (4)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Vance Thompson Vision- Bozeman
Bozeman, Montana, United States
Vance Thompson Vision- Omaha
Omaha, Nebraska, United States
Vance Thompson Vision- Fargo
Fargo, North Dakota, United States
Vance Thompson Vision- Sioux Falls
Sioux Falls, South Dakota, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07650708), the sponsor (Vance Thompson Vision), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07650708 clinical trial studying?

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) The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07650708?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07650708?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07650708. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07650708. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.