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| Name | Class |
|---|---|
| Bausch & Lomb Incorporated | INDUSTRY |
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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Miebo | Active Comparator | Miebo instilled four times per day to each eye |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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
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 -
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kayla Karpuk, OD | Contact | 605-371-6883 | kayla.karpuk@vancethompsonvision.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vance Thompson Vision- Bozeman | Recruiting | Bozeman | Montana | 59718 | United States |
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| Vance Thompson Vision- Omaha | Not yet recruiting | Omaha | Nebraska | 68137 | United States |
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| Vance Thompson Vision- Fargo | Recruiting | Fargo | North Dakota | 58078 | United States |
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| Vance Thompson Vision- Sioux Falls | Recruiting | Sioux Falls | South Dakota | 57108 | United States |
|
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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