Efficacy and Safety Evaluation of Tavilermide Ophthalmic Solution for the Treatment of Dry Eye
- Conditions
- Dry Eye SyndromesDry Eye DiseaseKerato Conjunctivitis Sicca
- Interventions
- Drug: 5% Tavilermide ophthalmic solutionOther: Vehicle ophthalmic solution
- Registration Number
- NCT05848128
- Lead Sponsor
- Mimetogen Pharmaceuticals USA, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 642
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 5% Tavilermide ophthalmic solution 5% Tavilermide ophthalmic solution - Vehicle ophthalmic solution Vehicle ophthalmic solution -
- Primary Outcome Measures
Name Time Method Change From Baseline in Total Corneal Fluorescein Staining as Measured by the NEI Scale Baseline to Day 85 The National Eye Institute (NEI) scale is a standardized grading system of 0-3 was used for each of the 5 areas on each cornea (central, superior, temporal, nasal, and inferior). Grade 0 was specified when no staining is present. The maximum score was 15.
Change From Baseline in Eye Dryness Score as Measured by the VAS Baseline to Day 85 The Visual Analog Scale (VAS) where subjects were asked to rate their eye dryness (OU) by placing a vertical mark on the horizontal line to indicate their current level of discomfort. 0 mm corresponds to "No Discomfort," and 100 mm corresponds to "Maximal Discomfort." The length of the assessment line is 100 mm.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (29)
Eye Associates of Fort Myers
🇺🇸Fort Myers, Florida, United States
Eye Consultants of Atlanta
🇺🇸Atlanta, Georgia, United States
Midwest Vision Research Foundation
🇺🇸Chesterfield, Missouri, United States
Advanced Laser Vision & Surgical Institute
🇺🇸Houston, Texas, United States
Eye Research Foundation
🇺🇸Newport Beach, California, United States
Eye Doctors of Arizona
🇺🇸Phoenix, Arizona, United States
Nature Coast Clinical Research
🇺🇸Crystal River, Florida, United States
Global Research Management
🇺🇸Glendale, California, United States
LoBue Laser and Eye Medical Center
🇺🇸Murrieta, California, United States
Total Eye Care
🇺🇸Memphis, Tennessee, United States
PNV Clinical Research
🇺🇸San Antonio, Texas, United States
Shettle Eye Research
🇺🇸Largo, Florida, United States
James D. Branch
🇺🇸Winston-Salem, North Carolina, United States
Toyos Clinic
🇺🇸Nashville, Tennessee, United States
Abrams Eye Center
🇺🇸Cleveland, Ohio, United States
Seidenberg Protzko Eye Associates
🇺🇸Havre De Grace, Maryland, United States
Scott & Christie and Associates
🇺🇸Cranberry Township, Pennsylvania, United States
Price Vision Group
🇺🇸Indianapolis, Indiana, United States
Oculus Research
🇺🇸Garner, North Carolina, United States
West Bay Eye Associates
🇺🇸Warwick, Rhode Island, United States
Lake Travis Eye & Laser Center/Revolution Research
🇺🇸Lakeway, Texas, United States
The Eye Institute of Utah
🇺🇸Salt Lake City, Utah, United States
Piedmont Eye Center
🇺🇸Lynchburg, Virginia, United States
Silverstein Eye Centers
🇺🇸Kansas City, Missouri, United States
Moyes Eye Center
🇺🇸Kansas City, Missouri, United States
Bowden Eye & Associates
🇺🇸Jacksonville, Florida, United States
Kannarr Eye Care
🇺🇸Pittsburg, Kansas, United States
Ophthalmology Associates
🇺🇸Saint Louis, Missouri, United States
Rochester Ophthalmological Group
🇺🇸Rochester, New York, United States