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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: Mimetogen Pharmaceuticals USA, Inc.

Current Primary Outcome:

• 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)
• 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

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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)
• Ocular Surface Disease Index [ Time Frame: Day 57 ]
• 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.

Original Secondary Outcome: Same as current

Information By: Mimetogen Pharmaceuticals USA, Inc.

Dates:
Date Received: January 20, 2016
Date Started: January 2016
Date Completion:
Last Updated: March 24, 2017
Last Verified: September 2016