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

Keratoconjunctivitis Sicca Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02665234
• Other study ID #: MIM-726
• Status: Completed
• Phase: Phase 3
• Start date: January 2016
• Est. completion date: March 2017

Study information

• Verified date: August 2019
• Source: Mimetogen Pharmaceuticals USA, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: March 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis
• Keratoconjunctivitis Sicca

Intervention

Drug:
• 1% Tavilermide Ophthalmic Solution
1% Tavilermide BID Dosing
• Placebo Ophthalmic Solution
Vehicle Ophthalmic Solution

Locations

Country	Name	City	State
United States	MIM-726 Investigational Site	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Mimetogen Pharmaceuticals USA, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Day 57
Primary	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	Day 57
Secondary	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)	Day 15
Secondary	Ocular Surface Disease Index		Day 57
Secondary	Ocular Dryness Using The Ora Calibra Scale	A patient-reported subjective assessment of ocular dryness recorded twice daily over the complete treatment period.	8 weeks