A Safety and Efficacy Study of Tavilermide (MIM-D3) Ophthalmic Solution for the Treatment of Dry Eye Disease

August 13, 2019 updated by: Mimetogen Pharmaceuticals USA, Inc.

A Safety and Efficacy Study of Tavilermide Ophthalmic Solution for the Treatment of Dry Eye Disease

The purpose of this study is to assess the safety and efficacy of Tavilermide Ophthalmic Solution compared with Placebo Ophthalmic Solution in treating the signs and symptoms of dry eye disease.

Study Overview

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Torrance, California, United States
        • MIM-726 Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Be at least 18 years of age.
  • Provided written informed consent.
  • Have a reported history of dry eye Have a history of use or desire to use eye drops for dry eye

Exclusion Criteria:

  • Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal) at Visit 1.
  • Be diagnosed with ocular rosacea, or any viral or bacterial disease of the cornea or conjunctiva, within the last 12 months.
  • Have any planned ocular and/or lid surgeries over the study period.
  • Have corrected visual acuity greater than or equal to +0.7 as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) scale in both eyes at Visit .
  • 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 known allergy and/or sensitivity to the test article or its components.
  • 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 of Visit 1 Be unable or unwilling to follow instructions, including participation in all study assessments and visits

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Tavilermide Ophthalmic Solution
1% Tavilermide Ophthalmic Solution
1% Tavilermide BID Dosing
Placebo Comparator: Vehicle Ophthalmic Solution
Placebo Ophthalmic Solution
Vehicle Ophthalmic Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Corneal Fluorescein Staining Using The Ora Calibra Scale
Time Frame: Day 57
An assessment of the total corneal fluorescein staining using the Ora Calibra Scale both immediately prior to and immediately following exposure to a challenge in a controlled adverse environment (CAE)
Day 57
Ocular Discomfort Using The Ora Calibra Scale
Time Frame: Day 57
A patient-reported subjective assessment of ocular discomfort recorded at each of the 5 office visits throughout the treatment period
Day 57

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Corneal Fluorescein Staining Using The Ora Calibra Scale
Time Frame: Day 15
An assessment of the total corneal fluorescein staining using the Ora Calibra Scale both immediately prior to and immediately following exposure to a challenge in a controlled adverse environment (CAE)
Day 15
Ocular Surface Disease Index
Time Frame: Day 57
Day 57
Ocular Dryness Using The Ora Calibra Scale
Time Frame: 8 weeks
A patient-reported subjective assessment of ocular dryness recorded twice daily over the complete treatment period.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

January 20, 2016

First Submitted That Met QC Criteria

January 22, 2016

First Posted (Estimate)

January 27, 2016

Study Record Updates

Last Update Posted (Actual)

August 16, 2019

Last Update Submitted That Met QC Criteria

August 13, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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