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

NCT02665234 | Completed Phase 3

• 1 other identifier: MIM-726
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Keratoconjunctivitis Sicca

Keywords

Dry Eye

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Total Corneal Fluorescein Staining Using The Ora Calibra Scale

  Day 15

• Ocular Surface Disease Index

  Day 57

• Ocular Dryness Using The Ora Calibra Scale

  8 weeks

Study Arms (2)

Tavilermide Ophthalmic Solution

ACTIVE COMPARATOR

1% Tavilermide Ophthalmic Solution

Drug: 1% Tavilermide Ophthalmic Solution

Vehicle Ophthalmic Solution

PLACEBO COMPARATOR

Placebo Ophthalmic Solution

Drug: Placebo Ophthalmic Solution

Interventions

1% Tavilermide Ophthalmic Solution DRUG

1% Tavilermide BID Dosing

Tavilermide Ophthalmic Solution

Placebo Ophthalmic Solution DRUG

Vehicle Ophthalmic Solution

Vehicle Ophthalmic Solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mimetogen Pharmaceuticals USA, Inc.: lead

Study Sites (1)

MIM-726 Investigational Site

Torrance, California, United States

Location

MeSH Terms

Conditions

Keratoconjunctivitis Sicca; Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Eye Diseases; Keratitis; Corneal Diseases; Lacrimal Apparatus Diseases

Study Officials

• Garth Cumberlidge, PhD

  Mimetogen Pharmaceuticals USA, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2016
• First Posted: January 27, 2016
• Study Start: January 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: March 1, 2017
• Last Updated: August 16, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)