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Assess the impact of concomitant Miebo use while wearing contact lenses
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Miebo (perfluorohexyloctane ophthalmic solution) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perfluorohexyloctane ophthalmic solution | Drug | Eligible subjects will receive Miebo up to 4 times bilaterally on Day 1/Visit 1 (1 drop instilled bilaterally by site staff in-clinic while wearing contact lenses and the rest self-administered throughout the remainder of the day while wearing contact lenses). Starting on Day 2, subjects will self-administer the first drop of Miebo bilaterally before inserting contact lenses for the day. Subjects will wait 30 minutes after the first dose of Miebo to insert their contact lenses and will then instill 3 additional drops of Miebo while wearing contact lenses approximately evenly spaced throughout the rest of the day. Subjects will continue to self-administer Miebo QID bilaterally following the dosing schedule from Day 2 for approximately 30 days. Subjects are expected to record daily VAS assessments throughout the study. The VAS assessments will be collected by the sites at Visits 2, 3, and 4. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline (CFB) in CLDEQ-8 score at Visit 4 | Unabbreviated scale title: Contact Lens Dry Eye Questionnaire-8 Min: 1 Max: 37 Higher scores mean worse. | Assessed for approximately 30 days |
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Inclusion Criteria:
Exclusion Criteria:
Subjects who do not have a documented Manifest Refraction within 180 days prior to Visit 1 by the Principal Investigator (or sub-investigator at the same site).
Subjects who are non-contact lens wearers or who have changed contact lens type/brand within the last 6 months
Subjects who wear scleral lenses, rigid gas-permeable lenses, hybrid lenses, custom soft contact lenses with a replacement schedule >30 days, or soft contact lenses on an extended-wear basis (i.e., AirOptix Night and Day contact lenses and other lenses approved for overnight wear)
Have any clinically significant ocular surface slit-lamp findings in either eye and/or, in the opinion of the Investigator, have any findings that could interfere with trial parameters or impact a subject's ability to wear contact lenses throughout the study, including:
Pterygium or pinguecula in either eye that, in the opinion of the Investigator, could interfere with fit of a soft contact lens
Use of any of the following ocular therapies in either eye within 30 days prior to Visit 1: Vuity®, topical ocular steroid treatments, topical antibiotics, topical anti-allergy medications, prescription dry eye therapy including varenicline nasal spray, or topical anti-glaucoma medication
Use of any eye drops (prescription or over-the-counter, such as artificial tears, re-wetting drops, RYZUMVITM, or Lumify®) and/or TrueTear™ device (intranasal tear neurostimulator) in either eye within 24 hours prior to Visit 1, or plan to use these therapies during the course of the study
Have active uncontrolled ocular allergies or ocular allergies that are expected to be active during the trial period
Have undergone intraocular surgery or ocular laser surgery in either eye within 3 months prior to Visit 1; have undergone refractive surgery in either eye within 1 year prior to Visit 1
Planning to undergo an ocular surgical intervention (e.g., intraocular surgery, ocular surgery, cataract surgery, LASIK, etc.) in either eye during the trial period.
Have active ocular or systemic infection (bacterial, viral, or fungal), including fever
Be unwilling to submit to a urine pregnancy test at Visits 1 and 4 for women of childbearing potential. Note: Females of childbearing potential include all females who have experienced menarche and have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months or have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy).
Female subjects who are pregnant, nursing, or planning a pregnancy
Female subjects of childbearing potential who are not using 1 acceptable method 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. True abstinence may be regarded as an acceptable method of birth control; however, if the subject becomes sexually active during the trial, she must agree to use 1 acceptable method of birth control as defined above for the remainder of the trial
Male subjects with a female partner of childbearing potential, who is not willing to use 1 acceptable method of birth control throughout the study. Note: Acceptable methods of birth control are true abstinence (when this is in line with the preferred and usual lifestyle of the subject) or unwilling to use condoms with spermicide if he has not had a vasectomy at least 3 months prior to receiving Investigational Product.
Have an uncontrolled systemic disease that, in the opinion of the Investigator, will interfere with the trial
Have a known allergy and/or sensitivity to the Investigational Product or diagnostic substances (e.g., fluorescein) to be used in the study
Are currently enrolled in any investigational drug or device study or have used Miebo within 30 days prior to Visit 1
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 101 | San Diego | California | 92307 | United States | ||
| Site 107 |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Longwood |
| Florida |
| 32779 |
| United States |
| Site 104 | Pittsburg | Kansas | 66762 | United States |
| Site 102 | Medina | Minnesota | 55340 | United States |
| Site 108 | Vestal | New York | 13850 | United States |
| Site 103 | Athens | Ohio | 45701 | United States |