Dry Eye Syndrome (DES)Phase 4SonoranNCT07650708
A Multicenter, Open-Label Study to Evaluate Perioperative Treatment of Dry Eye With Miebo® in Subjects Undergoing LASIK
A Phase 4 study testing Miebo four times per day in people with Dry Eye Syndrome (DES) and Dry Eye Disease (DED), run by Vance Thompson Vision at 4 sites in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndrome (DES), Dry Eye Disease (DED)
- What is being tested?
- Miebo four times per day
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesUnited States
- Study dates
- 5 May 2026to 1 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
- 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.
- Have a known allergy and/or sensitivity or lack of desired efficacy in response to the investigational drug
- 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 -
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Vance Thompson Vision- Bozeman
Bozeman, Montana, 59718
Brianna Cox, 605-206-2648, brianna.cox@vancethompsonvision.com
- Recruiting
Vance Thompson Vision- Fargo
Fargo, North Dakota, 58078
McKenzie Schueller, 701-205-0935, mckenzie.schueller@vancethompsonvision.com
- Not yet recruiting
Vance Thompson Vision- Omaha
Omaha, Nebraska, 68137
Sarah Hartnett, 402-899-8020, sarah.hartnett@vancethompsonvision.com
- Recruiting
Vance Thompson Vision- Sioux Falls
Sioux Falls, South Dakota, 57108
Kayla Karpuk, OD, 605-371-6883, kayla.karpuk@vancethompsonvision.com
About this study
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)
- Being tested
- Miebo four times per day
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Miebo four times per dayDrug
Single arm study where subjects dose with Miebo four times per day for one month before LASIK and for 1.5 months after LASIK
| Study group | Role | What they receive |
|---|---|---|
| Miebo | Active comparator | Miebo instilled four times per day to each eye Receives: Drug: Miebo four times per day |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start5 May 2026
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye Syndrome (DES)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vance Thompson Vision
- Sponsor type
- University, hospital or other
- Collaborators
- Bausch & Lomb Incorporated
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07650708
- Sponsor's protocol ID
- BL-RX01-SONORAN-1401
- Acronym
- Sonoran
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label Study to Evaluate Perioperative Treatment of Dry Eye With Miebo® in Subjects Undergoing LASIK
- ClinicalTrials.gov ID
- NCT07650708
- Acronym / sponsor ID
- Sonoran / BL-RX01-SONORAN-1401
- Conditions
- Dry Eye Syndrome (DES), Dry Eye Disease (DED)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Vance Thompson VisionUniversity, hospital or other
- Collaborators
- Bausch & Lomb Incorporated
- Study start
- 5 May 2026 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 16 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Miebo | Active comparator | Drug: Miebo four times per dayMiebo instilled four times per day to each eye |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (18 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Miebo four times per daySingle arm study where subjects dose with Miebo four times per day for one month before LASIK and for 1.5 months after LASIK | Drug | Miebo |
Primary outcome
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
Time frame: 4 months
Visual analog scole with a minimum score of 0 (lowest rating) and maximum score of 100 (highest rating)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Miebo four times per day in people with Dry Eye Syndrome (DES) and Dry Eye Disease (DED), run by Vance Thompson Vision at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kayla Karpuk, OD (605-371-6883, kayla.karpuk@vancethompsonvision.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.