Tavilermide Ophthalmic Solution for the Treatment of Dry Eye

Sponsor
Mimetogen Pharmaceuticals USA, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03925727
Collaborator
(none)
615
22
3
14.5
28
1.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: tavilermide ophthalmic solution
  • Other: Placebo
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
615 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Mar 28, 2019
Actual Primary Completion Date :
Jun 11, 2020
Actual Study Completion Date :
Jun 11, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1% tavilermide ophthalmic solution

Drug: tavilermide ophthalmic solution
BID topical dosing

Experimental: 5% tavilermide ophthalmic solution

Drug: tavilermide ophthalmic solution
BID topical dosing

Placebo Comparator: Vehicle ophthalmic solution

Other: Placebo
BID topical dosing

Outcome Measures

Primary Outcome Measures

  1. Change from baseline in Eye Dryness Score (VAS) [Day 85]

  2. Change from baseline in total Corneal Fluorescein Staining [Day 85]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
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

Site City State Country Postal Code
1 Tavilermide Investigational Site Phoenix Arizona United States 85032
2 Tavilermide Investigational Site Los Angeles California United States 90013
3 Tavilermide Investigational Site Newport Beach California United States 92663
4 Tavilermide Investigational Site Fort Collins Colorado United States 80528
5 Tavilermide Investigational Site Littleton Colorado United States 80120
6 Tavilermide Investigational Site Boynton Beach Florida United States 33437
7 Tavilermide Investigational Site Bradenton Florida United States 34209
8 Tavilermide Investigational Site Coral Springs Florida United States 33067
9 Tavilermide Investigational Site Ocala Florida United States 34474
10 Tavilermide Investigational Site Indianapolis Indiana United States 46290
11 Tavilermide Investigational Site Sioux City Iowa United States 51104
12 Tavilermide Investigational Site Lexington Kentucky United States 40509
13 Tavilermide Investigational Site Louisville Kentucky United States 40206
14 Tavilermide Investigational Site Saint Louis Missouri United States 63131
15 Tavilermide Investigational Site Shelby North Carolina United States 28150
16 Tavilermide Investigational Site Cincinnati Ohio United States 45236
17 Tavilermide Investigational Site Mason Ohio United States 45040
18 Tavilermide Investigational Site Rapid City South Dakota United States 57701
19 Tavilermide Investigational Site Maryville Tennessee United States 37803
20 Tavilermide Investigational Site Nashville Tennessee United States 37205
21 Tavilermide Investigational Site San Antonio Texas United States 78248
22 Tavilermide Investigational Site Kenosha Wisconsin United States 53142

Sponsors and Collaborators

  • Mimetogen Pharmaceuticals USA, Inc.

Investigators

  • Study Director: Karen Meerovitch, PhD, Mimetogen Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mimetogen Pharmaceuticals USA, Inc.
ClinicalTrials.gov Identifier:
NCT03925727
Other Study ID Numbers:
  • MIM-728
First Posted:
Apr 24, 2019
Last Update Posted:
Oct 22, 2021
Last Verified:
Oct 1, 2021
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 Oct 22, 2021