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

Primary Purpose

Keratoconjunctivitis Sicca

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

1% Tavilermide Ophthalmic Solution

Placebo Ophthalmic Solution

About this trial

This is an interventional treatment trial for Keratoconjunctivitis Sicca focused on measuring Dry Eye

Eligibility Criteria

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

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

Sites / Locations

MIM-726 Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Tavilermide Ophthalmic Solution

Vehicle Ophthalmic Solution

Arm Description

1% Tavilermide Ophthalmic Solution

Placebo Ophthalmic Solution

Outcomes

Primary Outcome Measures

Total Corneal Fluorescein Staining Using The Ora Calibra Scale

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)

Ocular Discomfort Using The Ora Calibra Scale

A patient-reported subjective assessment of ocular discomfort recorded at each of the 5 office visits throughout the treatment period

Secondary Outcome Measures

Total Corneal Fluorescein Staining Using The Ora Calibra Scale

Ocular Surface Disease Index

Ocular Dryness Using The Ora Calibra Scale

A patient-reported subjective assessment of ocular dryness recorded twice daily over the complete treatment period.

Full Information

NCT ID

NCT02665234

First Posted

January 20, 2016

Last Updated

August 13, 2019

Sponsor

Mimetogen Pharmaceuticals USA, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02665234

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

January 2016 (undefined)

Primary Completion Date

February 2017 (Actual)

Study Completion Date

March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mimetogen Pharmaceuticals USA, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Keratoconjunctivitis Sicca

Keywords

Dry Eye

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

400 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tavilermide Ophthalmic Solution

Arm Type

Active Comparator

Arm Description

1% Tavilermide Ophthalmic Solution

Arm Title

Vehicle Ophthalmic Solution

Arm Type

Placebo Comparator

Arm Description

Placebo Ophthalmic Solution

Intervention Type

Drug

Intervention Name(s)

1% Tavilermide Ophthalmic Solution

Intervention Description

1% Tavilermide BID Dosing

Intervention Type

Drug

Intervention Name(s)

Placebo Ophthalmic Solution

Intervention Description

Vehicle Ophthalmic Solution

Primary Outcome Measure Information:

Title

Total Corneal Fluorescein Staining Using The Ora Calibra Scale

Description

Time Frame

Day 57

Title

Ocular Discomfort Using The Ora Calibra Scale

Description

A patient-reported subjective assessment of ocular discomfort recorded at each of the 5 office visits throughout the treatment period

Time Frame

Day 57

Secondary Outcome Measure Information:

Title

Total Corneal Fluorescein Staining Using The Ora Calibra Scale

Description

Time Frame

Day 15

Title

Ocular Surface Disease Index

Time Frame

Day 57

Title

Ocular Dryness Using The Ora Calibra Scale

Description

A patient-reported subjective assessment of ocular dryness recorded twice daily over the complete treatment period.

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Garth Cumberlidge, PhD

Organizational Affiliation

Mimetogen Pharmaceuticals USA, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

MIM-726 Investigational Site

City

Torrance

State/Province

California

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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