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Tavilermide in dry eye disease
NCT02665234Phase 3
Key facts
- Status
- Completed
- Start
- Jan 2016
- Primary completion
- Feb 2017
- Countries
- 1
- Sponsor
- Mimetogen Pharmaceuticals
- Modality
- Small Molecules, Modified Peptides, Native Peptides
- Drugs
- tavilermide
- Conditions
- dry eye disease (DED)
01
Overview
Phase 3, randomised, double-blind trial in dry eye disease (DED) comparing Tavilermide 1% with Vehicle (2 arms). Primary endpoints: Total Corneal Fluorescein Staining Using The Ora Calibra Scale at Day 57 and Ocular Discomfort Using The Ora Calibra Scale at Day 57. Started Jan 2016; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Tavilermide 1%
1% Tavilermide Ophthalmic Solution BID
Vehicle
Placebo Ophthalmic Solution BID
03
Who it enrols
Adult patients with a history of dry eye disease and use/desire to use eye drops. Excludes patients with ocular infection, ocular rosacea, planned ocular surgeries, or uncontrolled systemic disease.
04
Endpoints
Primary
Total Corneal Fluorescein Staining Using The Ora Calibra Scale
Ocular Discomfort Using The Ora Calibra Scale
Secondary
Total Corneal Fluorescein Staining Using The Ora Calibra Scale
Ocular Surface Disease Index
Ocular Dryness Using The Ora Calibra Scale
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