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
1 other identifier
interventional
642
1 country
29
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2023
Shorter than P25 for phase_3
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2023
CompletedFirst Posted
Study publicly available on registry
May 8, 2023
CompletedStudy Start
First participant enrolled
June 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 11, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 11, 2024
CompletedJune 10, 2024
June 1, 2024
11 months
April 27, 2023
June 6, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
5% Tavilermide ophthalmic solution
EXPERIMENTALVehicle ophthalmic solution
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
Eye Doctors of Arizona
Phoenix, Arizona, 85003, United States
Global Research Management
Glendale, California, 91204, United States
LoBue Laser and Eye Medical Center
Murrieta, California, 92562, United States
Eye Research Foundation
Newport Beach, California, 92663, United States
Nature Coast Clinical Research
Crystal River, Florida, 34429, United States
Eye Associates of Fort Myers
Fort Myers, Florida, 33901, United States
Bowden Eye & Associates
Jacksonville, Florida, 32256, United States
Shettle Eye Research
Largo, Florida, 33773, United States
Eye Consultants of Atlanta
Atlanta, Georgia, 30339, United States
Price Vision Group
Indianapolis, Indiana, 46260, United States
Kannarr Eye Care
Pittsburg, Kansas, 66762, United States
Seidenberg Protzko Eye Associates
Havre de Grace, Maryland, 21078, United States
Midwest Vision Research Foundation
Chesterfield, Missouri, 63017, United States
Silverstein Eye Centers
Kansas City, Missouri, 64133, United States
Moyes Eye Center
Kansas City, Missouri, 64154, United States
Ophthalmology Associates
St Louis, Missouri, 63131, United States
Rochester Ophthalmological Group
Rochester, New York, 14618, United States
Oculus Research
Garner, North Carolina, 27529, United States
James D. Branch
Winston-Salem, North Carolina, 27101, United States
Abrams Eye Center
Cleveland, Ohio, 44115, United States
Scott & Christie and Associates
Cranberry Township, Pennsylvania, 16066, United States
West Bay Eye Associates
Warwick, Rhode Island, 02888, United States
Total Eye Care
Memphis, Tennessee, 38119, United States
Toyos Clinic
Nashville, Tennessee, 37215, United States
Advanced Laser Vision & Surgical Institute
Houston, Texas, 77034, United States
Lake Travis Eye & Laser Center/Revolution Research
Lakeway, Texas, 78738, United States
PNV Clinical Research
San Antonio, Texas, 78229, United States
The Eye Institute of Utah
Salt Lake City, Utah, 84107, United States
Piedmont Eye Center
Lynchburg, Virginia, 24502, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2023
First Posted
May 8, 2023
Study Start
June 28, 2023
Primary Completion
May 11, 2024
Study Completion
May 11, 2024
Last Updated
June 10, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share