A Phase 1/ Phase 2 Study of TTHX1114(NM141)

• Status: Completed
• Trial end date: 2021-05-18
• Target enrollment: 0
• Participant gender: All

Summary

Prospective, multicenter, randomized, masked, vehicle-controlled, dose-escalation study that includes a non-interventional observational sub-study in which subjects will undergo (standard) ocular assessments

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Trefoil Therapeutics, Inc.

Criteria

Key Inclusion Criteria:

• Fuchs Endothelial Corneal Dystrophy, pseudophakic bullous keratopathy, or endothelial dysfunction/ insufficiency due to surgical intervention diagnosed more than 6 months prior to Study Day 0

• Central endothelial cell count of < 2000 mm^2 in at least one eye as determined by the central reading facility

Key Exclusion Criteria:

• Conditions that would impair examination of the anterior chamber structure

• Documented repeated elevated intra ocular pressure (in either eye)

• Corneal transplant (in either eye)

• Posterior Polymorphous Corneal Dystrophy (PPCD)

• History of uveitis or herpetic keratitis

• Cataract surgery within the past 3 months

• Refractive surgery (in the Study Eye)

• Anterior Chamber IOL placement (in the Study Eye)

• Active extra-ocular inflammation from any non-infectious or infectious cause within the past 6 months

• Expected or planned ocular surgery within the next 3 months

• Use of cytotoxic chemotherapy within the last 1 month

• Treatment with a rho kinase inhibitor within the last 3 months

• Use of cyclosporine ophthalmic emulsion or lifitegrast ophthalmic solution in the last 30 days

• Systemic or ophthalmic corticosteroid use in the 30 days prior to Study Day 0 unless approved by the Medical Monitor

• History of significant allergy, hypersensitivity, or intolerance to any drug compound, food, or other substance

• Unwilling to use birth control