A Study to Evaluate Corneal Endothelial Cell Density (ECD) in Subjects With Dry Eye Disease (DED)… (NCT06565650) | Clinical Trial Compass
Active — Not RecruitingPhase 4
A Study to Evaluate Corneal Endothelial Cell Density (ECD) in Subjects With Dry Eye Disease (DED) Administering Miebo® (Perfluorohexyloctane Ophthalmic Solution) for 12 Months.
United States216 participantsStarted 2024-07-31
Plain-language summary
A Randomized, Multicenter, Double-Masked, Saline-Controlled Trial to Evaluate Corneal Endothelial Cell Density in Subjects With Dry Eye Disease Administering Miebo® (Perfluorohexyloctane Ophthalmic Solution) for 12 Months
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
✓. Be at least 18 years of age at the time of consent.
✓. Have a self-reported history of DED in both eyes (OU) for at least 6 months prior to Visit 1 (Screening/Baseline)
✓. Have a total corneal fluorescein staining score (tCFS) score \>2 in both eyes
✓. Have an Ocular Surface Disease Index (OSDI) score \>17
✓. Have a baseline ECD ≥1750 cells/mm2 in each eye
✓. Provide written informed consent
✓. Be able and willing to follow instructions, including participation in all trial assessments and visits
✓. If a contact lens wearer, be willing to discontinue contact lens use during and for 30 minutes following instillation of investigational drug and during study visits
Exclusion criteria
✕. Be at least 18 years of age at the time of consent.
✕. Have a self-reported history of DED in both eyes (OU) for at least 6 months prior to Visit 1 (Screening/Baseline)
✕. Have a total corneal fluorescein staining score (tCFS) score \>2 in both eyes
✕. Have an Ocular Surface Disease Index (OSDI) score \>17
✕. Have a baseline ECD ≥1750 cells/mm2 in each eye
What they're measuring
1
Mean change from baseline in ECD
Timeframe: Assessed at Month 3 and Month 12 Visits
✕. Be able and willing to follow instructions, including participation in all trial assessments and visits
✕. If a contact lens wearer, be willing to discontinue contact lens use during and for 30 minutes following instillation of investigational drug and during study visits