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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Dry Eye Syndromes; Dry Eye Disease; Kerato Conjunctivitis Sicca
• Intervention / Treatment: Drug: 5% Tavilermide ophthalmic solution; Other: Vehicle ophthalmic solution

• Study Type: Interventional
• Enrollment (Actual): 642
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: VP, Clinical Research; Phone Number: 972-965-3247; Email: lacey.powers@oculoscr.com

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85003
      • Eye Doctors of Arizona
  • California
    • Glendale, California, United States, 91204
      • Global Research Management
    • Murrieta, California, United States, 92562
      • LoBue Laser and Eye Medical Center
    • Newport Beach, California, United States, 92663
      • Eye Research Foundation
  • Florida
    • Crystal River, Florida, United States, 34429
      • Nature Coast Clinical Research
    • Fort Myers, Florida, United States, 33901
      • Eye Associates of Fort Myers
    • Jacksonville, Florida, United States, 32256
      • Bowden Eye & Associates
    • Largo, Florida, United States, 33773
      • Shettle Eye Research
  • Georgia
    • Atlanta, Georgia, United States, 30339
      • Eye Consultants of Atlanta
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Price Vision Group
  • Kansas
    • Pittsburg, Kansas, United States, 66762
      • Kannarr Eye Care
  • Maryland
    • Havre De Grace, Maryland, United States, 21078
      • Seidenberg Protzko Eye Associates
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • Midwest Vision Research Foundation
    • Kansas City, Missouri, United States, 64154
      • Moyes Eye Center
    • Kansas City, Missouri, United States, 64133
      • Silverstein Eye Centers
    • Saint Louis, Missouri, United States, 63131
      • Ophthalmology Associates
  • New York
    • Rochester, New York, United States, 14618
      • Rochester Ophthalmological Group
  • North Carolina
    • Garner, North Carolina, United States, 27529
      • Oculus Research
    • Winston-Salem, North Carolina, United States, 27101
      • James D. Branch
  • Ohio
    • Cleveland, Ohio, United States, 44115
      • Abrams Eye Center
  • Pennsylvania
    • Cranberry Township, Pennsylvania, United States, 16066
      • Scott & Christie and Associates
  • Rhode Island
    • Warwick, Rhode Island, United States, 02888
      • West Bay Eye Associates
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Total Eye Care
    • Nashville, Tennessee, United States, 37215
      • Toyos Clinic
  • Texas
    • Houston, Texas, United States, 77034
      • Advanced Laser Vision & Surgical Institute
    • Lakeway, Texas, United States, 78738
      • Lake Travis Eye & Laser Center/Revolution Research
    • San Antonio, Texas, United States, 78229
      • PNV Clinical Research
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • The Eye Institute of Utah
  • Virginia
    • Lynchburg, Virginia, United States, 24502
      • Piedmont Eye Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Vehicle ophthalmic solution	Other: Vehicle ophthalmic solution; Twice a day topical dosing
Experimental: 5% Tavilermide ophthalmic solution	Drug: 5% Tavilermide ophthalmic solution; Twice a day topicial dosing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Mimetogen Pharmaceuticals USA, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2023
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: April 27, 2023
• First Submitted That Met QC Criteria: April 27, 2023
• First Posted (Actual): May 8, 2023

Study Record Updates

• Last Update Posted (Actual): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Conjunctivitis; Keratoconjunctivitis; Ophthalmic Solutions; Pharmaceutical Solutions
• Other Study ID Numbers: MIM-729

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