Tavilermide Ophthalmic Solution for the Treatment of Dry Eye

April 4, 2023 updated by: Mimetogen Pharmaceuticals USA, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

623

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Tavilermide Investigational Site
    • California
      • Los Angeles, California, United States, 90013
        • Tavilermide Investigational Site
      • Newport Beach, California, United States, 92663
        • Tavilermide Investigational Site
    • Colorado
      • Fort Collins, Colorado, United States, 80528
        • Tavilermide Investigational Site
      • Littleton, Colorado, United States, 80120
        • Tavilermide Investigational Site
    • Florida
      • Boynton Beach, Florida, United States, 33437
        • Tavilermide Investigational Site
      • Bradenton, Florida, United States, 34209
        • Tavilermide Investigational Site
      • Coral Springs, Florida, United States, 33067
        • Tavilermide Investigational Site
      • Ocala, Florida, United States, 34474
        • Tavilermide Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46290
        • Tavilermide Investigational Site
    • Iowa
      • Sioux City, Iowa, United States, 51104
        • Tavilermide Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Tavilermide Investigational Site
      • Louisville, Kentucky, United States, 40206
        • Tavilermide Investigational Site
    • Missouri
      • Saint Louis, Missouri, United States, 63131
        • Tavilermide Investigational Site
    • North Carolina
      • Shelby, North Carolina, United States, 28150
        • Tavilermide Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45236
        • Tavilermide Investigational Site
      • Mason, Ohio, United States, 45040
        • Tavilermide Investigational Site
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Tavilermide Investigational Site
    • Tennessee
      • Maryville, Tennessee, United States, 37803
        • Tavilermide Investigational Site
      • Nashville, Tennessee, United States, 37205
        • Tavilermide Investigational Site
    • Texas
      • San Antonio, Texas, United States, 78248
        • Tavilermide Investigational Site
    • Wisconsin
      • Kenosha, Wisconsin, United States, 53142
        • Tavilermide Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Vehicle ophthalmic solution
Other: Placebo
BID topical dosing
Experimental: 1% Tavilermide ophthalmic solution
Drug: Tavilermide ophthalmic solution
BID topical dosing
Experimental: 5% Tavilermide ophthalmic solution
Drug: Tavilermide ophthalmic solution
BID topical dosing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Eye Dryness Score as Measured by the VAS
Time Frame: 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.
Baseline to Day 85 in 5% Tavilermide versus Placebo
Change From Baseline in Total Corneal Fluorescein Staining as Measured by the NEI Scale
Time Frame: 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.
Baseline to Day 85 in 5% Tavilermide versus Placebo

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mimetogen Pharmaceuticals USA, Inc.

Investigators

  • Study Director: Karen Meerovitch, PhD, Mimetogen Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2019

Primary Completion (Actual)

June 11, 2020

Study Completion (Actual)

June 11, 2020

Study Registration Dates

First Submitted

April 19, 2019

First Submitted That Met QC Criteria

April 19, 2019

First Posted (Actual)

April 24, 2019

Study Record Updates

Last Update Posted (Actual)

April 5, 2023

Last Update Submitted That Met QC Criteria

April 4, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIM-728

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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