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

Primary Purpose

Dry Eye Syndromes, Dry Eye Disease, Kerato Conjunctivitis Sicca

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
5% Tavilermide ophthalmic solution
Vehicle ophthalmic solution
Sponsored by
Mimetogen Pharmaceuticals USA, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndromes

Eligibility Criteria

18 Years - undefined (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

  • Eye Doctors of ArizonaRecruiting
  • Global Research ManagementRecruiting
  • LoBue Laser and Eye Medical CenterRecruiting
  • Eye Research FoundationRecruiting
  • Nature Coast Clinical ResearchRecruiting
  • Eye Associates of Fort MyersRecruiting
  • Bowden Eye & AssociatesRecruiting
  • Shettle Eye ResearchRecruiting
  • Eye Consultants of AtlantaRecruiting
  • Price Vision GroupRecruiting
  • Kannarr Eye CareRecruiting
  • Silverstein Eye CentersRecruiting
  • Moyes Eye CenterRecruiting
  • Ophthalmology AssociatesRecruiting
  • Rochester Ophthalmological GroupRecruiting
  • Oculus ResearchRecruiting
  • James D. BranchRecruiting
  • Abrams Eye CenterRecruiting
  • Scott & Christie and AssociatesRecruiting
  • West Bay Eye AssociatesRecruiting
  • Total Eye CareRecruiting
  • Toyos ClinicRecruiting
  • Advanced Laser Vision & Surgical InstituteRecruiting
  • Lake Travis Eye & Laser Center/Revolution ResearchRecruiting
  • PNV Clinical ResearchRecruiting
  • The Eye Institute of UtahRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

5% Tavilermide ophthalmic solution

Vehicle ophthalmic solution

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
April 27, 2023
Last Updated
October 4, 2023
Sponsor
Mimetogen Pharmaceuticals USA, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05848128
Brief Title
Efficacy and Safety Evaluation of Tavilermide Ophthalmic Solution for the Treatment of Dry Eye
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 28, 2023 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
5% Tavilermide ophthalmic solution
Arm Type
Experimental
Arm Title
Vehicle ophthalmic solution
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
5% Tavilermide ophthalmic solution
Intervention Description
Twice a day topicial dosing
Intervention Type
Other
Intervention Name(s)
Vehicle ophthalmic solution
Intervention Description
Twice a day topical dosing
Primary Outcome Measure Information:
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.
Time Frame
Baseline to Day 85
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
VP, Clinical Research
Phone
972-965-3247
Email
lacey.powers@oculoscr.com
Facility Information:
Facility Name
Eye Doctors of Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85003
Country
United States
Individual Site Status
Recruiting
Facility Name
Global Research Management
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Individual Site Status
Recruiting
Facility Name
LoBue Laser and Eye Medical Center
City
Murrieta
State/Province
California
ZIP/Postal Code
92562
Country
United States
Individual Site Status
Recruiting
Facility Name
Eye Research Foundation
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Individual Site Status
Recruiting
Facility Name
Nature Coast Clinical Research
City
Crystal River
State/Province
Florida
ZIP/Postal Code
34429
Country
United States
Individual Site Status
Recruiting
Facility Name
Eye Associates of Fort Myers
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Individual Site Status
Recruiting
Facility Name
Bowden Eye & Associates
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Individual Site Status
Recruiting
Facility Name
Shettle Eye Research
City
Largo
State/Province
Florida
ZIP/Postal Code
33773
Country
United States
Individual Site Status
Recruiting
Facility Name
Eye Consultants of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30339
Country
United States
Individual Site Status
Recruiting
Facility Name
Price Vision Group
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Individual Site Status
Recruiting
Facility Name
Kannarr Eye Care
City
Pittsburg
State/Province
Kansas
ZIP/Postal Code
66762
Country
United States
Individual Site Status
Recruiting
Facility Name
Silverstein Eye Centers
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64133
Country
United States
Individual Site Status
Recruiting
Facility Name
Moyes Eye Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64154
Country
United States
Individual Site Status
Recruiting
Facility Name
Ophthalmology Associates
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Individual Site Status
Recruiting
Facility Name
Rochester Ophthalmological Group
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Individual Site Status
Recruiting
Facility Name
Oculus Research
City
Garner
State/Province
North Carolina
ZIP/Postal Code
27529
Country
United States
Individual Site Status
Recruiting
Facility Name
James D. Branch
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27101
Country
United States
Individual Site Status
Recruiting
Facility Name
Abrams Eye Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44115
Country
United States
Individual Site Status
Recruiting
Facility Name
Scott & Christie and Associates
City
Cranberry Township
State/Province
Pennsylvania
ZIP/Postal Code
16066
Country
United States
Individual Site Status
Recruiting
Facility Name
West Bay Eye Associates
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02888
Country
United States
Individual Site Status
Recruiting
Facility Name
Total Eye Care
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Individual Site Status
Recruiting
Facility Name
Toyos Clinic
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Individual Site Status
Recruiting
Facility Name
Advanced Laser Vision & Surgical Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77034
Country
United States
Individual Site Status
Recruiting
Facility Name
Lake Travis Eye & Laser Center/Revolution Research
City
Lakeway
State/Province
Texas
ZIP/Postal Code
78738
Country
United States
Individual Site Status
Recruiting
Facility Name
PNV Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
The Eye Institute of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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