Tavilermide Ophthalmic Solution for the Treatment of Dry Eye

Dry Eye Clinical Trial

Official title:

Multi-Center, Randomized,Double-Masked, Vehicle-Controlled Study to Assess the Safety and Efficacy Study of Tavilermide Ophthalmic Solutions for the Treatment of Dry Eye

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03925727
• Other study ID #: MIM-728
• Status: Completed
• Phase: Phase 3
• Start date: March 28, 2019
• Est. completion date: June 11, 2020

Study information

• Verified date: March 2023
• Source: Mimetogen Pharmaceuticals USA, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 623
• Est. completion date: June 11, 2020
• Est. primary completion date: June 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Tavilermide ophthalmic solution
BID topical dosing

Other:
• Placebo
BID topical dosing

Locations

Country	Name	City	State
United States	Tavilermide Investigational Site	Boynton Beach	Florida
United States	Tavilermide Investigational Site	Bradenton	Florida
United States	Tavilermide Investigational Site	Cincinnati	Ohio
United States	Tavilermide Investigational Site	Coral Springs	Florida
United States	Tavilermide Investigational Site	Fort Collins	Colorado
United States	Tavilermide Investigational Site	Indianapolis	Indiana
United States	Tavilermide Investigational Site	Kenosha	Wisconsin
United States	Tavilermide Investigational Site	Lexington	Kentucky
United States	Tavilermide Investigational Site	Littleton	Colorado
United States	Tavilermide Investigational Site	Los Angeles	California
United States	Tavilermide Investigational Site	Louisville	Kentucky
United States	Tavilermide Investigational Site	Maryville	Tennessee
United States	Tavilermide Investigational Site	Mason	Ohio
United States	Tavilermide Investigational Site	Nashville	Tennessee
United States	Tavilermide Investigational Site	Newport Beach	California
United States	Tavilermide Investigational Site	Ocala	Florida
United States	Tavilermide Investigational Site	Phoenix	Arizona
United States	Tavilermide Investigational Site	Rapid City	South Dakota
United States	Tavilermide Investigational Site	Saint Louis	Missouri
United States	Tavilermide Investigational Site	San Antonio	Texas
United States	Tavilermide Investigational Site	Shelby	North Carolina
United States	Tavilermide Investigational Site	Sioux City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Mimetogen Pharmaceuticals USA, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Eye Dryness Score as Measured by the VAS	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.	Baseline to Day 85 in 5% Tavilermide versus Placebo
Primary	Change From Baseline in Total Corneal Fluorescein Staining as Measured by the NEI Scale	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.	Baseline to Day 85 in 5% Tavilermide versus Placebo