A Study to Evaluate Concomitant Perfluorohexyloctane Use With Contact Lens Wear (NCT07054606) | Clinical Trial Compass
CompletedPhase 4
A Study to Evaluate Concomitant Perfluorohexyloctane Use With Contact Lens Wear
United States104 participantsStarted 2025-07-02
Plain-language summary
Assess the impact of concomitant Miebo use while wearing contact lenses
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. At least 18 years of age at the time of consent
✓. Able to provide written voluntary informed consent and sign the Health Insurance Portability and Accountability Act (HIPAA) form as well as the Experimental Subjects Bill of Rights(for subjects in California)
✓. Subject must have a documented Manifest Refraction by the PI (or sub-investigator at the same site) performed in the past 180 days prior to screening.
Exclusion criteria
✕. Achieves acceptable lens fit as well as ETDRS VA correctable with contact lenses to +0.20 logMAR or better in each eye at Visit 1
✕. Able and willing to follow instructions, including participation in all trial assessments and visits
✕. Be willing to submit to urine pregnancy test at Visits 1 and 4 for female subjects of childbearing potential.
✕. Female subjects of childbearing potential must agree to use 1 medically 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 (when this is in line with the preferred and usual lifestyle of the subject); however, if the subject becomes sexually active during the trial, she must use an acceptable method of birth control as defined above for the remainder of the trial. 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).
✕. Male subjects with a female partner of childbearing potential, must use at least 1 medically acceptable method of birth control. Note: Acceptable methods of birth control are true abstinence (when this is in line with the preferred and usual lifestyle of the subject) or vasectomy at least 3 months prior to receiving Investigational Product. Without a vasectomy, condoms with spermicide must be used throughout the study duration.
✕. 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
What they're measuring
1
Change from baseline (CFB) in CLDEQ-8 score at Visit 4
✕. 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)