Overview

This trial is active, not recruiting.

Condition keratoconjunctivitis sicca
Treatments 1% tavilermide ophthalmic solution, placebo ophthalmic solution
Phase phase 3
Sponsor Mimetogen Pharmaceuticals USA, Inc.
Start date December 2015
End date September 2016
Trial size 400 participants
Trial identifier NCT02634853, MIM-727

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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
1% Tavilermide Ophthalmic Solution
1% tavilermide ophthalmic solution
1% Tavilermide BID Dosing
(Placebo Comparator)
Placebo Ophthalmic Solution
placebo ophthalmic solution
Vehicle Ophthalmic Solution

Primary Outcomes

Measure
Corneal Fluorescein Staining
time frame: Day 57
Ocular Discomfort
time frame: Day 57

Secondary Outcomes

Measure
Corneal Fluorescein Staining
time frame: Day 15
Ocular Surface Disease Index
time frame: Day 57
Ocular Dryness
time frame: 8 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria

    Exclusion Criteria

      Additional Information

      Official title A Safety and Efficacy Study of Tavilermide Ophthalmic Solution for the Treatment of Dry Eye
      Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
      Information provided to ClinicalTrials.gov by Mimetogen Pharmaceuticals USA, Inc..