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NCT04391894 · ClinicalTrials.gov registry record · Phase 2
A Study to Assess the Safety and Efficacy of ECF843 vs Vehicle in Subjects With Dry Eye Disease
A Phase 2 study of Dry Eye, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 718
- Enrollment target
- 20
- Study locations
NCT04391894: Completed Phase 2 study of Dry Eye, sponsored by Novartis Pharmaceuticals.
NCT04391894 is a Phase 2 study of Dry Eye that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 718 participants, above the 78-participant average among 41 other Dry Eye trials with a reported enrollment target (821% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04391894, a Phase 2 study of Dry Eye, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 718 participants
- Enrollment target
- 20
- Study locations
Study Summary
The study was planned to be conducted in 2 parts: Part 1 to determine the efficacy and safety of ECF843 vs vehicle, followed by Part 2 with additional exploratory assessments of ECF843 vs Vehicle. Both parts of the study included a double-masked study design, with randomization stratified for subjects with Sjogren's Syndrome.
Primary Outcome
The SANDE uses a 100 mm visual analog scale (VAS) and asks the subject to score frequency and severity of their ocular discomfort over the past 24 hours by putting a vertical mark on two separate horizontal scoring lines. The frequency scoring line utilizes the anchors of 'Rarely' to 'All the Time', while the severity scoring line utilizes the anchors of 'Very Mildly' to 'Very Severely uncomfortable'. The SANDE questionnaire was completed through an electronic diary by the subject at the Screeni
Conditions Studied
Interventions
- DRUG ECF843
- OTHER ECF843 vehicle
Study Locations (20)
California
- Milton Hom OD - Azusa
- Orange County Opthamology Med Grp - Garden Grove
- Dr Kent Small - Glendale
- Global Research Management - Glendale
- United Medical Research Institute - Inglewood
- Harvard Eye Associates - Laguna Hills
- North Valley Eye Medical Group - Mission Hills
- The Eye Research Foundation - Newport Beach
- North Bay Eye Associates Inc - Petaluma
- Martel Eye Medical Group - Rancho Cordova
- Sierra Clin Trials Rsch Org - Santa Ana
Florida
- Advanced Research LLC - Deerfield Beach
- Pinnacle Research Institute - Fort Lauderdale
- Eye Associates Of Fort Myers - Fort Myers
- Lee Shettle Eye & Hearing - Largo
- Mid Florida Eye Center Pa - Mt. Dora
Arizona
- Arizona Eye Center - Chandler
- Carrot Eye Center - Mesa
- Phoenix Eye Care and Dry Eye Ctr - Phoenix
Colorado
- Vision Institute - Colorado Springs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 718 participants |
| Start Date | 2020-10-06 |
| Est. Completion | 2021-05-13 |
| Phase | Phase 2 |
What the finished NCT04391894 record still lists
NCT04391894 is an interventional study that assigns participants to a tested intervention. The registered 718 participants enrollment target is mid-sized for trials with a published cap, above the 78-participant average among 41 other Dry Eye trials with a reported enrollment target (821% higher).
The record links to 1 condition, with Dry Eye appearing as the primary indexed condition, and to 2 interventions - of which ECF843 is the first listed.
NCT04391894 names 20 study sites across 4 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT04391894 about?
NCT04391894 is a clinical study titled "A Study to Assess the Safety and Efficacy of ECF843 vs Vehicle in Subjects With Dry Eye Disease". The study was planned to be conducted in 2 parts: Part 1 to determine the efficacy and safety of ECF843 vs vehicle, followed by Part 2 with additional exploratory assessments of ECF843 vs Vehicle. Both parts of the study included a double-masked study design, with randomization stratified for subjec...
What is the current status of trial NCT04391894?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 718 participants. The study started on 2020-10-06. Estimated completion is 2021-05-13.
What conditions does trial NCT04391894 study?
This clinical trial studies the following conditions: Dry Eye.
What interventions are being tested in trial NCT04391894?
The interventions under investigation include: ECF843 (DRUG), ECF843 vehicle (OTHER).
Who is sponsoring clinical trial NCT04391894?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04391894 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Dry Eye
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04391894's enrollment target sits among peer trials
718 1st of 41 higher than 41 of 41 other Dry Eye trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dry Eye trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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