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

Sponsor
Mimetogen Pharmaceuticals USA, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05848128
Collaborator
(none)
630
2
10

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: 5% Tavilermide ophthalmic solution
  • Other: Vehicle ophthalmic solution
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
630 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 5% Tavilermide ophthalmic solution

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

Placebo Comparator: Vehicle ophthalmic solution

Other: Vehicle ophthalmic solution
Twice a day topical dosing

Outcome Measures

Primary Outcome Measures

  1. Change From Baseline in Total Corneal Fluorescein Staining as Measured by the NEI Scale [Baseline to Day 85]

    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.

  2. Change From Baseline in Eye Dryness Score as Measured by the VAS [Baseline to Day 85]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Mimetogen Pharmaceuticals USA, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mimetogen Pharmaceuticals USA, Inc.
ClinicalTrials.gov Identifier:
NCT05848128
Other Study ID Numbers:
  • MIM-729
First Posted:
May 8, 2023
Last Update Posted:
May 8, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 8, 2023