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A Study to Assess the Safety and Efficacy of ECF843 vs Vehicle in Subjects With Dry Eye Disease
NCT04391894 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04391894
The ClinicalTrials.gov registry entry for NCT04391894 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 718 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 792 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04391894 reports 20 study locations spanning 4 distinct geographic areas — top geographies include California, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04391894?
The interventions under investigation include: ECF843 (DRUG), ECF843 vehicle (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04391894?
This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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