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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 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.

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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.

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

FieldValue
Enrollment Target 718 participants
Start Date 2020-10-06
Est. Completion 2021-05-13
Phase Phase 2

Sponsor

Novartis Pharmaceuticals

1,375 total trials

What the Registry Record Tells You About NCT04391894

The ClinicalTrials.gov registry entry for NCT04391894 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 718 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 78-participant average among 41 other Dry Eye trials with a reported enrollment target (821% higher). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 4 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.