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Completed

NCT Number: NCT02665234

A Safety and Efficacy Study of Tavilermide (MIM-D3) 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.

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Key information

Conditions

Keratoconjunctivitis Sicca Conjunctival Diseases Conjunctivitis Corneal Diseases Dry Eye Syndromes Eye Diseases Keratitis Keratoconjunctivitis Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

MIM-726 Investigational Site

Torrance, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

1% Tavilermide Ophthalmic Solution

Drug

1% Tavilermide BID Dosing

Placebo Ophthalmic Solution

Drug

Vehicle Ophthalmic Solution

Primary outcomes

  1. 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)

  2. 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

Secondary outcomes

  1. 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)

  2. Ocular Surface Disease Index

    Time frame: Day 57

  3. 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.

Sponsors and collaborators

Lead sponsor

Mimetogen Pharmaceuticals USA, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 27, 2016
Registry last updated
Aug 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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