NCT02653391 - A Study Investigating the Safety, Tolerability, and Efficacy of Elamipretide Topical Ophthalmic Solution for the Treatment of Fuchs' Corneal Endothelial Dystrophy (FCED) | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

February 29, 2016

Primary Completion Date

March 31, 2018

Study Completion Date

December 31, 2018

Conditions

Fuchs' Corneal Endothelial Dystrophy (FCED)

Interventions

DRUG

Part A Elamipretide 1.0% Ophthalmic Solution

Part A Each subject will receive one drop of elamipretide 1.0% ophthalmic solution BID in the randomly selected study eye.

DRUG

Part B Elamipretide 3.0% Ophthalmic Solution

Part B Each subject will receive one drop of elamipretide 3.0% ophthalmic solution BID in both eyes.

DRUG

Part A Placebo

Part A Each subject will receive one drop of vehicle ophthalmic solution BID in the paired eye of the randomly selected study eye.

DRUG

Part B Placebo

Part B: Each subject will receive one drop of vehicle ophthalmic solution BID in both eyes.

Trial Locations (2)

Cincinnati Eye Institute, Edgewood

Ophthalmic Consultants of Boston, Boston

All Listed Sponsors

lead

Stealth BioTherapeutics Inc.

INDUSTRY