Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
22 participants
INTERVENTIONAL
2020-08-19
2021-05-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Vehicle (placebo)
Placebo weekly x 4
Vehicle (placebo)
Placebo
Low dose
TTHX1114(NM141) low-dose weekly x 4
TTHX1114(NM141)
engineered FGF-1 delivered intracamerally
Mid-dose
TTHX1114(NM141) mid-dose weekly x 4
TTHX1114(NM141)
engineered FGF-1 delivered intracamerally
High-dose
TTHX1114(NM141) high-dose weekly x 4
TTHX1114(NM141)
engineered FGF-1 delivered intracamerally
Interventions
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TTHX1114(NM141)
engineered FGF-1 delivered intracamerally
Vehicle (placebo)
Placebo
Eligibility Criteria
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Inclusion Criteria
* Central endothelial cell count of \< 2000 mm\^2 in at least one eye as determined by the central reading facility
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Trefoil Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Thomas M Tremblay, RN BSN
Role: STUDY_DIRECTOR
Trefoil Therapeutics
Locations
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North Bay Eye Associates, Inc.
Petaluma, California, United States
Levenson Eye Associates, Inc
Jacksonville, Florida, United States
Chicago Corneal Consultants
Hoffman Estates, Illinois, United States
Price Vision Group
Indianapolis, Indiana, United States
Tauber Eye Center
Kansas City, Missouri, United States
Vance Thompson Vision - Omaha
Omaha, Nebraska, United States
Alterman, Modi and Wolter
Poughkeepsie, New York, United States
Vance Thompson Vision - Sioux Falls
Sioux Falls, South Dakota, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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TTHX-001
Identifier Type: -
Identifier Source: org_study_id
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