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Tavilermide Ophthalmic Solution for the Treatment of Dry Eye

Primary Purpose

Keratoconjunctivitis Sicca, Dry Eye

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tavilermide ophthalmic solution
Placebo
Sponsored by
Mimetogen Pharmaceuticals USA, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconjunctivitis Sicca

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tavilermide Investigational Site
  • Tavilermide Investigational Site
  • Tavilermide Investigational Site
  • Tavilermide Investigational Site
  • Tavilermide Investigational Site
  • Tavilermide Investigational Site
  • Tavilermide Investigational Site
  • Tavilermide Investigational Site
  • Tavilermide Investigational Site
  • Tavilermide Investigational Site
  • Tavilermide Investigational Site
  • Tavilermide Investigational Site
  • Tavilermide Investigational Site
  • Tavilermide Investigational Site
  • Tavilermide Investigational Site
  • Tavilermide Investigational Site
  • Tavilermide Investigational Site
  • Tavilermide Investigational Site
  • Tavilermide Investigational Site
  • Tavilermide Investigational Site
  • Tavilermide Investigational Site
  • Tavilermide Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

1% Tavilermide ophthalmic solution

5% Tavilermide ophthalmic solution

Vehicle ophthalmic solution

Arm Description

Outcomes

Primary Outcome Measures

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.
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. Study eye is the 'worse eye', defined as the eye with worse (higher) score at baseline.

Secondary Outcome Measures

Full Information

First Posted
April 19, 2019
Last Updated
April 4, 2023
Sponsor
Mimetogen Pharmaceuticals USA, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03925727
Brief Title
Tavilermide Ophthalmic Solution for the Treatment of Dry Eye
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
March 28, 2019 (Actual)
Primary Completion Date
June 11, 2020 (Actual)
Study Completion Date
June 11, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mimetogen Pharmaceuticals USA, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconjunctivitis Sicca, Dry Eye

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
623 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1% Tavilermide ophthalmic solution
Arm Type
Experimental
Arm Title
5% Tavilermide ophthalmic solution
Arm Type
Experimental
Arm Title
Vehicle ophthalmic solution
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Tavilermide ophthalmic solution
Intervention Description
BID topical dosing
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
BID topical dosing
Primary Outcome Measure Information:
Title
Change From Baseline in Eye Dryness Score as Measured by the VAS
Description
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.
Time Frame
Baseline to Day 85 in 5% Tavilermide versus Placebo
Title
Change From Baseline in Total Corneal Fluorescein Staining as Measured by the NEI Scale
Description
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.
Time Frame
Baseline to Day 85 in 5% Tavilermide versus Placebo

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Meerovitch, PhD
Organizational Affiliation
Mimetogen Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Tavilermide Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Tavilermide Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90013
Country
United States
Facility Name
Tavilermide Investigational Site
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Tavilermide Investigational Site
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
Tavilermide Investigational Site
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
Tavilermide Investigational Site
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33437
Country
United States
Facility Name
Tavilermide Investigational Site
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34209
Country
United States
Facility Name
Tavilermide Investigational Site
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33067
Country
United States
Facility Name
Tavilermide Investigational Site
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
Tavilermide Investigational Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Tavilermide Investigational Site
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51104
Country
United States
Facility Name
Tavilermide Investigational Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Tavilermide Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40206
Country
United States
Facility Name
Tavilermide Investigational Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Tavilermide Investigational Site
City
Shelby
State/Province
North Carolina
ZIP/Postal Code
28150
Country
United States
Facility Name
Tavilermide Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Tavilermide Investigational Site
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States
Facility Name
Tavilermide Investigational Site
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Tavilermide Investigational Site
City
Maryville
State/Province
Tennessee
ZIP/Postal Code
37803
Country
United States
Facility Name
Tavilermide Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Tavilermide Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78248
Country
United States
Facility Name
Tavilermide Investigational Site
City
Kenosha
State/Province
Wisconsin
ZIP/Postal Code
53142
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Tavilermide Ophthalmic Solution for the Treatment of Dry Eye

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