A Study to Evaluate Corneal Endothelial Cell Density (ECD) in Subjects With Dry Eye Disease (DED) Administering Miebo® (Perfluorohexyloctane Ophthalmic Solution) for 12 Months.
NCT06565650 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 216
Last updated 2024-12-17
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
Conditions
- Dry Eye
Interventions
- DRUG
-
Miebo
100% perfluorohexyloctane
- DRUG
-
Saline
0.6% sodium chloride solution
Sponsors & Collaborators
-
Bausch & Lomb Incorporated
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-07-31
- Primary Completion
- 2025-11-30
- Completion
- 2025-11-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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