DT-168 in Keratoplasty Patients With Fuchs Endothelial Corneal Dystrophy

A Phase 2, Multicenter, Open-Label Study to Assess the Pharmacodynamics, Safety, and Tolerability of DT-168 Ophthalmic Solution in Patients With Fuchs Endothelial Corneal Dystrophy Undergoing Keratoplasty

The purpose of this study is to evaluate the pharmacodynamics, safety, and tolerability of DT-168 Ophthalmic Solution in pre-keratoplasty patients with Fuchs endothelial corneal dystrophy.

Inclusion Criteria:

• Participant is scheduled to undergo a keratoplasty for management of FECD independent of this study.
• ≥30 years of age (inclusive).
• Documented diagnosis of FECD in the study eligible eye.
• Confirmation of positive TCF4 allele 18.1 CTG expansion in at least one allele.
• Capable of giving signed informed consent.

Exclusion Criteria:

• Any ocular or medical condition in the study eligible eye which is clinically significant or would confound study results or data interpretation.
• Any clinically significant medical, nonmedical, and psychiatric disorders that could put the participant at higher risk for participation in the study, impair the participant's ability to participate in the study, or interfere with interpretation of the participant's study results, in the opinion of the investigator.
• Concurrent or anticipated need for treatment for FECD, eg, Muro 128 (2% or 5%) during the course of the study in the study eye. Provided the subject undergoes a washout of Muro drops for at least 24 hours prior to the Baseline Visit, they will not be excluded.
• Concurrent or anticipated use of topical corticosteroids in the study eye.
• Concurrent use with Rhopressa®, Rocklatan®, or any other ocular Rho Kinase inhibitor.
• Known contraindication, allergy, or hypersensitivity to any of the treatments, anesthetics, or diagnostic agents or components thereof which may be used during the study.
• Use of contact lenses in the study eye within 7 days prior to the Baseline Visit or planned use during the study.
• Recent (within 30 days of the Screening Visit) or ongoing participation in any other investigational interventional clinical study.
• Female participant is pregnant, planning a pregnancy, or breast-feeding.
• Participant is unwilling to comply with the contraceptive requirements, as per protocol.