BridgeMD
New treatment option for Dry Eye Syndrome (DES)
Official title A Multicenter, Open-Label Study to Evaluate Perioperative Treatment of Dry Eye With Miebo® in Subjects Undergoing LASIK
ClinicalTrials.gov ID: NCT07650708
What this study is testing
What is Miebo four times per day?
Miebo four times per day is an investigational medicine, being studied as a potential treatment for dry eye syndrome (des).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Be a candidate for routine, uncomplicated bilateral LASIK surgery (for spherical equivalent [≤-8.00D] myopia or myopic astigmatism correction, not...
- 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 likely can't join if
- Have any clinically significant ocular surface slit-lamp findings in the study eye that, in the opinion of the Investigator, could interfere with...
- 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...
- 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...
- Use of any eye drops (prescription or over the counter) in the study eye within 24 hours prior to Visit 1
See the full eligibility criteria
- 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...
- 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
- 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...
- 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...
- 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 people who are pregnant, nursing, or planning a pregnancy
- Female people 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...
- Have a known allergy and/or sensitivity or lack of desired how well it works 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 -
The study team makes the final eligibility decision.
Where it's taking place
- Bozeman, Montana, United States
- Omaha, Nebraska, United States
- Fargo, North Dakota, United States
- Sioux Falls, South Dakota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bozeman, Montana, United States; Omaha, Nebraska, United States; Fargo, North Dakota, United States; Sioux Falls, South Dakota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.