Efficacy and Safety Evaluation of Tavilermide Ophthalmic Solution for the Treatment of Dry Eye
NCT ID: NCT05848128
Last Updated: 2024-06-10
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
PHASE3
642 participants
INTERVENTIONAL
2023-06-28
2024-05-11
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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5% Tavilermide ophthalmic solution
5% Tavilermide ophthalmic solution
Twice a day topicial dosing
Vehicle ophthalmic solution
Vehicle ophthalmic solution
Twice a day topical dosing
Interventions
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5% Tavilermide ophthalmic solution
Twice a day topicial dosing
Vehicle ophthalmic solution
Twice a day topical dosing
Eligibility Criteria
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Inclusion Criteria
* History of use of artificial tear eye drops for dry eye symptoms;
* Total score of ≥40 on SANDE;
* TFBUT;
* Corneal fluorescein staining;
* Lissamine green conjunctival staining;
* Schirmer's test score.
Exclusion Criteria
* Have clinically significant slit lamp findings at Visit 1;
* Have a history of lacrimal duct obstruction within 12 months of Visit 1;
* Have an uncontrolled systemic disease;
* Be a woman who is pregnant, nursing or planning a pregnancy;
* Be a woman of childbearing potential who is not using an acceptable means of birth control;
* Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study;
* Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 45 days prior to Visit 1.
18 Years
ALL
No
Sponsors
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Mimetogen Pharmaceuticals USA, Inc.
INDUSTRY
Responsible Party
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Locations
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Eye Doctors of Arizona
Phoenix, Arizona, United States
Global Research Management
Glendale, California, United States
LoBue Laser and Eye Medical Center
Murrieta, California, United States
Eye Research Foundation
Newport Beach, California, United States
Nature Coast Clinical Research
Crystal River, Florida, United States
Eye Associates of Fort Myers
Fort Myers, Florida, United States
Bowden Eye & Associates
Jacksonville, Florida, United States
Shettle Eye Research
Largo, Florida, United States
Eye Consultants of Atlanta
Atlanta, Georgia, United States
Price Vision Group
Indianapolis, Indiana, United States
Kannarr Eye Care
Pittsburg, Kansas, United States
Seidenberg Protzko Eye Associates
Havre de Grace, Maryland, United States
Midwest Vision Research Foundation
Chesterfield, Missouri, United States
Silverstein Eye Centers
Kansas City, Missouri, United States
Moyes Eye Center
Kansas City, Missouri, United States
Ophthalmology Associates
St Louis, Missouri, United States
Rochester Ophthalmological Group
Rochester, New York, United States
Oculus Research
Garner, North Carolina, United States
James D. Branch
Winston-Salem, North Carolina, United States
Abrams Eye Center
Cleveland, Ohio, United States
Scott & Christie and Associates
Cranberry Township, Pennsylvania, United States
West Bay Eye Associates
Warwick, Rhode Island, United States
Total Eye Care
Memphis, Tennessee, United States
Toyos Clinic
Nashville, Tennessee, United States
Advanced Laser Vision & Surgical Institute
Houston, Texas, United States
Lake Travis Eye & Laser Center/Revolution Research
Lakeway, Texas, United States
PNV Clinical Research
San Antonio, Texas, United States
The Eye Institute of Utah
Salt Lake City, Utah, United States
Piedmont Eye Center
Lynchburg, Virginia, United States
Countries
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Other Identifiers
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MIM-729
Identifier Type: -
Identifier Source: org_study_id
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