A Study to Assess the Safety and Efficacy of ECF843 vs Vehicle in Subjects With Dry Eye Disease
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Dry Eye
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Triple (Participant, Care Provider, Investigator)Masking Description: Double-maskedPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The study will be conducted in 2 parts: Part 1 - efficacy and safety of ECF843 vs vehicle, followed by Part 2 - exploratory assessment of ECF843 vs vehicle. Part 1 uses a double-masked design where subjects will be randomized to receive BID or TID treatment with either ECF843 or vehicle for 56 days....
The study will be conducted in 2 parts: Part 1 - efficacy and safety of ECF843 vs vehicle, followed by Part 2 - exploratory assessment of ECF843 vs vehicle. Part 1 uses a double-masked design where subjects will be randomized to receive BID or TID treatment with either ECF843 or vehicle for 56 days. Part 2 will be initiated only if safety and efficacy of ECF843 during Part 1 is demonstrated. Part 2 is double-masked design of ECF843 versus vehicle for 84 days after a 2-week vehicle run-in phase. Approximately 800 subjects will need to be screened in Part 1 to have approximately 680 subjects randomized into the 56-day treatment period. For Part 2, it is estimated that up to 200 subjects will need to be screened to randomize up to 160 subjects into the 2 treatment arms.
Tracking Information
- NCT #
- NCT04391894
- Collaborators
- Not Provided
- Investigators
- Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
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