A Study to Assess the Safety and Efficacy of ECF843 vs Vehicle in Subjects With Dry Eye Disease

A Randomized, Double-masked, Multicenter Study to Evaluate the Safety and Efficacy of ECF843 vs Vehicle in Subjects With Dry Eye Disease

ClinicalTrials.gov Identifier: NCT04391894

Novartis Reference Number: CECF843A2201

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

The purpose of Part 1 of the study is to determine the safety and efficacy of topical ocular ECF843 compared to topical ocular vehicle for the relief of the signs and symptoms associated with moderate to severe dry eye disease (DED).

Part 2 of the study is exploratory only and intended to explore potential areas of differentiation between ECF843 and Xiidra® (lifitegrast 5% ophthalmic solution) for the treatment of subjects with dry eye disease.

Condition 
Dry Eye
Phase 
Phase 2
Overall status 
Recruiting
Enrollment count 
680 participants
Start date 
Oct 06, 2020
Completion date 
Apr 18, 2022
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
ECF843 0.45 mg/mL
Topical ocular eye drop administered 3 times per day (TID)
Drug
ECF843 0.15 mg/mL
Topical ocular eye drop 2 or 3 times/day (BID orTID)
Other
ECF843 vehicle
Topical ocular eye drop 2 or 3 times/day (BID orTID)
Drug
ECF843 mg/mL
Topical ocular eye drop (concentration and dosing frequency to be determined from Part 1).
Drug
Xiidra®
Topical ocular eye drop administered twice per day (BID)

Eligibility Criteria

Inclusion Criteria:

Written informed consent must be obtained before any assessment
Adult male or female subjects 18 years of age or older
At least 6 months history of dry eye disease in both eyes
Must use, or feel the need to use, artificial tears/gels/lubricants on a regular basis
Composite corneal fluorescein staining score ≥ 4 (modified National Eye Institute (NEI) scale) in at least one eye
Schirmer score ≥ 1 and ≤ 10 mm after 5 minutes in at least one eye
Patients with Sjögren's Syndrome

Exclusion Criteria:

Ocular infection in either eye within 30 days prior to Screening
Use of artificial tears, gels, lubricants within 4 hours of the Screening Visit
Use of contact lenses in either eye within 14 days of Screening
Uncontrolled ocular rosacea
Clinically significant conjunctivochalasis in either eye
Corneal conditions
Severe ocular conditions such as herpes, graft versus host disease, Stephen's Johnson Syndrome, sarcoidosis
Currently active, or history of ocular allergies during the time of year the patient will be participating in the study
Patients with current punctal plugs or punctal cauterization or occlusion
Chronic medications (both over the counter and prescription) that have not been stable for at least 30 days prior to Screening.
Use of Restasis®, Cequa®, or Xiidra® within 30 days prior to Screening
Use of ocular, nasal, inhaled, or systemic corticosteroids within 30 days of Screening
History of malignancy of any organs system
Pregnant or nursing women

Study Locations

United States
Novartis Investigative Site
Recruiting
Azusa, 91702
California
United States
Novartis Investigative Site
Recruiting
Glendale, 91203
California
United States
Novartis Investigative Site
Recruiting
Glendale, 91205
California
United States
Novartis Investigative Site
Recruiting
Inglewood, 90301
California
United States
Novartis Investigative Site
Recruiting
Mission Hills, 91345
California
United States
Novartis Investigative Site
Recruiting
Rancho Cordova, 95670
California
United States
Novartis Investigative Site
Recruiting
Fort Lauderdale, 33309
Florida
United States
Novartis Investigative Site
Recruiting
Largo, 33773
Florida
United States
Novartis Investigative Site
Recruiting
Mount Dora, 32757
Florida
United States
Novartis Investigative Site
Recruiting
Kansas City, 64133
Missouri
United States
Novartis Investigative Site
Recruiting
Saint Louis, 63128
Missouri
United States
Novartis Investigative Site
Recruiting
Washington, 63090
Missouri
United States
Novartis Investigative Site
Recruiting
Las Vegas, 89123
Nevada
United States
Novartis Investigative Site
Recruiting
South Orange, 07079
New Jersey
United States
Novartis Investigative Site
Recruiting
Cleveland, 44115
Ohio
United States
Novartis Investigative Site
Recruiting
Mason, 45040
Ohio
United States
Novartis Investigative Site
Recruiting
Cranberry Township, 16066
Pennsylvania
United States
Novartis Investigative Site
Recruiting
Maryville, 37803
Tennessee
United States
Novartis Investigative Site
Recruiting
Memphis, 38119
Tennessee
United States
Novartis Investigative Site
Recruiting
Nashville, 37205
Tennessee
United States
Novartis Investigative Site
Recruiting
Nashville, 37215
Tennessee
United States
Novartis Investigative Site
Recruiting
Smyrna, 37167
Tennessee
United States
Novartis Investigative Site
Recruiting
Austin, 78731
Texas
United States
Novartis Investigative Site
Recruiting
Houston, 77005
Texas
United States
Novartis Investigative Site
Recruiting
Lakeway, 78738
Texas
United States
Novartis Investigative Site
Recruiting
Salt Lake City, 84117
Utah
United States
Novartis Investigative Site
Recruiting
Lynchburg, 24502
Virginia
United States

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Name: 
Novartis Pharmaceuticals
Phone: 
Email: 

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Call 1-999-669-6682 or email [email protected]