Tavilermide Ophthalmic Solution for the Treatment of Dry Eye
- Conditions
- Dry EyeKeratoconjunctivitis Sicca
- Interventions
- Other: Placebo
- Registration Number
- NCT03925727
- Lead Sponsor
- Mimetogen Pharmaceuticals USA, Inc.
- Brief Summary
The purpose of this study is to assess the safety and efficacy of 5% tavilermide and 1% tavilermide ophthalmic solutions compared with placebo ophthalmic solution in treating the signs and symptoms of dry eye.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 623
- 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 1% Tavilermide ophthalmic solution Tavilermide ophthalmic solution - Vehicle ophthalmic solution Placebo - 5% Tavilermide ophthalmic solution Tavilermide ophthalmic solution -
- Primary Outcome Measures
Name Time Method Change From Baseline in Eye Dryness Score as Measured by the VAS Baseline to Day 85 in 5% Tavilermide versus Placebo 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.
Change From Baseline in Total Corneal Fluorescein Staining as Measured by the NEI Scale Baseline to Day 85 in 5% Tavilermide versus Placebo 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. Study eye is the 'worse eye', defined as the eye with worse (higher) score at baseline.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Tavilermide Investigational Site
🇺🇸Kenosha, Wisconsin, United States