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.

Bausch & Lomb Incorporated12 sites in 1 country216 target enrollmentJuly 31, 2024

ConditionsDry Eye

InterventionsMiebo Saline

DrugsMiebo Saline

Overview

Phase: Phase 4
Intervention: Miebo
Conditions: Dry Eye
Sponsor: Bausch & Lomb Incorporated
Enrollment: 216
Locations: 12
Primary Endpoint: Mean change from baseline in ECD
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

July 31, 2024

End Date

November 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bausch & Lomb Incorporated

Responsible Party

Sponsor

Eligibility Criteria

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
•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
•Have any clinically significant ocular surface slit lamp findings and/or in the opinion of the Investigator have any findings that may interfere with trial parameters in either eye
•Have an ocular or periocular malignancy in either eye