Efficacy and Safety Evaluation of Tavilermide Ophthalmic Solution for the Treatment of Dry Eye

Dry Eye Syndromes Clinical Trial

Official title:

A Phase 3, Multicenter, Randomized, Double-Masked, Vehicle-Controlled Clinical Study to Assess the Efficacy and Safety of 5% Tavilermide Ophthalmic Solution for the Treatment of Dry Eye

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05848128
• Other study ID #: MIM-729
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: June 28, 2023
• Est. completion date: May 2024

Study information

• Verified date: January 2024
• Source: Mimetogen Pharmaceuticals USA, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 642
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

• Conjunctivitis
• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Kerato Conjunctivitis Sicca
• Keratoconjunctivitis
• Keratoconjunctivitis Sicca

Intervention

Drug:
• 5% Tavilermide ophthalmic solution
Twice a day topicial dosing

Other:
• Vehicle ophthalmic solution
Twice a day topical dosing

Locations

Country	Name	City	State
United States	Eye Consultants of Atlanta	Atlanta	Georgia
United States	Midwest Vision Research Foundation	Chesterfield	Missouri
United States	Abrams Eye Center	Cleveland	Ohio
United States	Scott & Christie and Associates	Cranberry Township	Pennsylvania
United States	Nature Coast Clinical Research	Crystal River	Florida
United States	Eye Associates of Fort Myers	Fort Myers	Florida
United States	Oculus Research	Garner	North Carolina
United States	Global Research Management	Glendale	California
United States	Seidenberg Protzko Eye Associates	Havre De Grace	Maryland
United States	Advanced Laser Vision & Surgical Institute	Houston	Texas
United States	Price Vision Group	Indianapolis	Indiana
United States	Bowden Eye & Associates	Jacksonville	Florida
United States	Moyes Eye Center	Kansas City	Missouri
United States	Silverstein Eye Centers	Kansas City	Missouri
United States	Lake Travis Eye & Laser Center/Revolution Research	Lakeway	Texas
United States	Shettle Eye Research	Largo	Florida
United States	Piedmont Eye Center	Lynchburg	Virginia
United States	Total Eye Care	Memphis	Tennessee
United States	LoBue Laser and Eye Medical Center	Murrieta	California
United States	Toyos Clinic	Nashville	Tennessee
United States	Eye Research Foundation	Newport Beach	California
United States	Eye Doctors of Arizona	Phoenix	Arizona
United States	Kannarr Eye Care	Pittsburg	Kansas
United States	Rochester Ophthalmological Group	Rochester	New York
United States	Ophthalmology Associates	Saint Louis	Missouri
United States	The Eye Institute of Utah	Salt Lake City	Utah
United States	PNV Clinical Research	San Antonio	Texas
United States	West Bay Eye Associates	Warwick	Rhode Island
United States	James D. Branch	Winston-Salem	North Carolina

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 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.	Baseline to Day 85
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