Tavilermide Ophthalmic Solution for the Treatment of Dry Eye
NCT ID: NCT03925727
Last Updated: 2023-04-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
623 participants
INTERVENTIONAL
2019-03-28
2020-06-11
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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1% Tavilermide ophthalmic solution
Tavilermide ophthalmic solution
BID topical dosing
5% Tavilermide ophthalmic solution
Tavilermide ophthalmic solution
BID topical dosing
Vehicle ophthalmic solution
Placebo
BID topical dosing
Interventions
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Tavilermide ophthalmic solution
BID topical dosing
Placebo
BID 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
99 Years
ALL
No
Sponsors
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Mimetogen Pharmaceuticals USA, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Karen Meerovitch, PhD
Role: STUDY_DIRECTOR
Mimetogen Pharmaceuticals
Locations
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Tavilermide Investigational Site
Phoenix, Arizona, United States
Tavilermide Investigational Site
Los Angeles, California, United States
Tavilermide Investigational Site
Newport Beach, California, United States
Tavilermide Investigational Site
Fort Collins, Colorado, United States
Tavilermide Investigational Site
Littleton, Colorado, United States
Tavilermide Investigational Site
Boynton Beach, Florida, United States
Tavilermide Investigational Site
Bradenton, Florida, United States
Tavilermide Investigational Site
Coral Springs, Florida, United States
Tavilermide Investigational Site
Ocala, Florida, United States
Tavilermide Investigational Site
Indianapolis, Indiana, United States
Tavilermide Investigational Site
Sioux City, Iowa, United States
Tavilermide Investigational Site
Lexington, Kentucky, United States
Tavilermide Investigational Site
Louisville, Kentucky, United States
Tavilermide Investigational Site
St Louis, Missouri, United States
Tavilermide Investigational Site
Shelby, North Carolina, United States
Tavilermide Investigational Site
Cincinnati, Ohio, United States
Tavilermide Investigational Site
Mason, Ohio, United States
Tavilermide Investigational Site
Rapid City, South Dakota, United States
Tavilermide Investigational Site
Maryville, Tennessee, United States
Tavilermide Investigational Site
Nashville, Tennessee, United States
Tavilermide Investigational Site
San Antonio, Texas, United States
Tavilermide Investigational Site
Kenosha, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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MIM-728
Identifier Type: -
Identifier Source: org_study_id
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