Efficacy and Safety Evaluation of Tavilermide Ophthalmic Solution for the Treatment of Dry Eye
Completed · Phase 3
Conditions studied: Dry Eye Syndromes, Dry Eye Disease, Kerato Conjunctivitis Sicca
In brief
The purpose of the study is to compare the efficacy and safety of 5% tavilermide ophthalmic solution to placebo for the treatment of the signs and symptoms of dry eye disease.
Key facts
- Study ID
- NCT05848128
- Run by
- Mimetogen Pharmaceuticals USA, Inc.
- People needed
- 642
- Starts
- 2023-06-28
- Expected to finish
- 2024-05-11
- Last updated by the study team
- 2024-06-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subject-reported history of dry eye disease in both eyes for at least 6 months;
- 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.
You may not qualify if…
- Have participated in a previous tavilermide (MIM-D3) study;
- 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.
Where it is running
- 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
Full record on ClinicalTrials.gov
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