A Phase 1/ Phase 2 Study of TTHX1114(NM141) (NCT04520321) | Clinical Trial Compass
CompletedPhase 1/2
A Phase 1/ Phase 2 Study of TTHX1114(NM141)
United States22 participantsStarted 2020-08-19
Plain-language summary
Prospective, multicenter, randomized, masked, vehicle-controlled, dose-escalation study
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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