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

Sponsor

Mimetogen Pharmaceuticals USA, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT02665234

Collaborator

(none)

400

Enrollment

Location

Arms

Duration (Months)

28.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Keratoconjunctivitis Sicca	Drug: 1% Tavilermide Ophthalmic Solution Drug: Placebo Ophthalmic Solution	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2016

Actual Primary Completion Date :

Feb 1, 2017

Actual Study Completion Date :

Mar 1, 2017

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Tavilermide Ophthalmic Solution

1% Tavilermide Ophthalmic Solution

Drug: 1% Tavilermide Ophthalmic Solution

1% Tavilermide BID Dosing

Placebo Comparator: Vehicle Ophthalmic Solution

Placebo Ophthalmic Solution

Drug: Placebo Ophthalmic Solution

Vehicle Ophthalmic Solution

Outcome Measures

Primary Outcome Measures

Total Corneal Fluorescein Staining Using The Ora Calibra Scale [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)
Ocular Discomfort Using The Ora Calibra Scale [Day 57]
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 [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)
Ocular Surface Disease Index [Day 57]
Ocular Dryness Using The Ora Calibra Scale [8 weeks]
A patient-reported subjective assessment of ocular dryness recorded twice daily over the complete treatment period.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

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