Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
49 participants
INTERVENTIONAL
2021-02-01
2023-01-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1 DWEK/DSO
Study subjects in Group 1 will undergo DWEK/ DSO and will not receive any TTHX1114
No interventions assigned to this group
Group 2 TTHX1114 in combination with DWEK/DSO
Study subjects in Group 2 will receive TTHX1114 (5 injections) and undergo DWEK/ DSO
TTHX1114(NM141)
TTHX1114
Group 3 TTHX1114 in combination with DWEK/DSO
Study subjects in Group 3 will receive TTHX1114 (1 injection) and undergo DWEK/ DSO
TTHX1114(NM141)
TTHX1114
Group 1a
Study subjects in Group 1a will consist of subjects in Group 1 if not recovered from DWEK/ DSO by Day 84 and will receive TTHX1114 (5 injections)
TTHX1114(NM141)
TTHX1114
Group 3a
Study subjects in Group 3a will consist of subjects who had participated in in Group 3 if not recovered from DWEK/ DSO by the median time observed in Group 2 and will receive TTHX1114 (4 injections)
TTHX1114(NM141)
TTHX1114
Interventions
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TTHX1114(NM141)
TTHX1114
Eligibility Criteria
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Inclusion Criteria
* Scheduled for DWEK/DSO with a planned central descemetorhexis of approx 4 to 5 mm
* Subjects in Group 2 must have a stable Fellow Eye with adequate function
Exclusion Criteria
* Prior refractive surgery in the Study Eye
* Prior exposure to TTHX1114
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 Tremblay
Role: STUDY_DIRECTOR
Trefoil Therapeutics.com
Locations
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Trefoil Investigational Site 124
Long Beach, California, United States
North Bay Eye Associates
Petaluma, California, United States
Trefoil Investigational Site 123
Deerfield Beach, Florida, United States
Trefoil Investigational Site 119
Fort Myers, Florida, United States
Price Vision Group
Indianapolis, Indiana, United States
Tauber Eye Center
Kansas City, Missouri, United States
Vance Thompson Vision - Bozeman
Bozeman, Montana, United States
Vance Thompson Vision - Omaha
Omaha, Nebraska, United States
Vance Thompson Vision - Fargo
West Fargo, North Dakota, United States
Trefoil Investigational Site 120
Cincinnati, Ohio, United States
Vance Thompson Vision - Sioux Falls
Sioux Falls, South Dakota, United States
Countries
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References
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Moloney G, Al-Zanki S, Burgos-Blasco B, Fadaifard Martinez M, Bujak M, Dhaliwal DK. Severe Corneal Flattening After Endothelial Keratoplasty: Collagen Compaction Syndrome. Cornea. 2024 Nov 7;44(5):653-658. doi: 10.1097/ICO.0000000000003752.
Other Identifiers
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TTHX-002
Identifier Type: -
Identifier Source: org_study_id
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