A Study to Assess the Safety and Efficacy of ECF843 vs Vehicle in Subjects With Dry Eye Disease
NCT ID: NCT04391894
Last Updated: 2025-01-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
718 participants
INTERVENTIONAL
2020-10-06
2021-05-13
Brief Summary
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Detailed Description
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* ECF843 0.45 mg/mL three times daily (TID) or vehicle
* ECF843 0.15 mg/mL TID or vehicle
* ECF843 vehicle TID
* ECF843 0.15 mg/mL twice daily (BID) or vehicle
* ECF843 vehicle BID The planned duration of double-masked treatment during Part 1 was 56 days. For subjects randomized to ECF843, the maximum drug exposure was up to 28 days. At some point during Part 1, all participants received vehicle.
The study was terminated after completion of Part 1 and Part 2 of the study was not therefore initiated.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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ECF843 0.45 mg/mL TID or vehicle (Part 1)
ECF843 0.45 mg/mL TID or vehicle (Part 1)
ECF843
Topical ocular eye drop
ECF843 vehicle
Topical ocular eye drop
ECF843 0.15 mg/mL TID or vehicle (Part 1)
ECF843 0.15 mg/mL TID or vehicle (Part 1)
ECF843
Topical ocular eye drop
ECF843 vehicle
Topical ocular eye drop
ECF843 vehicle TID (Part 1)
ECF843 vehicle TID (Part 1)
ECF843 vehicle
Topical ocular eye drop
ECF843 0.15 mg/mL BID or vehicle (Part 1)
ECF843 0.15 mg/mL BID or vehicle (Part 1)
ECF843
Topical ocular eye drop
ECF843 vehicle
Topical ocular eye drop
ECF843 vehicle BID (Part 1)
ECF843 vehicle BID (Part 1)
ECF843 vehicle
Topical ocular eye drop
Interventions
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ECF843
Topical ocular eye drop
ECF843 vehicle
Topical ocular eye drop
Eligibility Criteria
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Inclusion Criteria
* 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 must have dry eye
Exclusion Criteria
* 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
* Other Corneal conditions affecting the corneal structure
* 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 organ system within the past five years
* Pregnant or nursing women
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Arizona Eye Center
Chandler, Arizona, United States
Carrot Eye Center
Mesa, Arizona, United States
Phoenix Eye Care and Dry Eye Ctr
Phoenix, Arizona, United States
Milton Hom OD
Azusa, California, United States
Orange County Opthamology Med Grp
Garden Grove, California, United States
Dr Kent Small
Glendale, California, United States
Global Research Management
Glendale, California, United States
United Medical Research Institute
Inglewood, California, United States
Harvard Eye Associates
Laguna Hills, California, United States
North Valley Eye Medical Group
Mission Hills, California, United States
The Eye Research Foundation
Newport Beach, California, United States
North Bay Eye Associates Inc
Petaluma, California, United States
Martel Eye Medical Group
Rancho Cordova, California, United States
Sierra Clin Trials Rsch Org
Santa Ana, California, United States
Vision Institute
Colorado Springs, Colorado, United States
Advanced Research LLC
Deerfield Beach, Florida, United States
Pinnacle Research Institute
Fort Lauderdale, Florida, United States
Eye Associates Of Fort Myers
Fort Myers, Florida, United States
Lee Shettle Eye & Hearing
Largo, Florida, United States
Mid Florida Eye Center Pa
Mt. Dora, Florida, United States
Kannarr Eye Care
Pittsburg, Kansas, United States
The Eye Care Institute
Louisville, Kentucky, United States
Tufts Medical Center
Boston, Massachusetts, United States
Silverstein Eye Centers
Kansas City, Missouri, United States
Moyes Eye Center
Kansas City, Missouri, United States
Tekwani Vision Center
St Louis, Missouri, United States
Comprehensive Eye Care Limited
Washington, Missouri, United States
NV Eye Surgery
Henderson, Nevada, United States
AdvanceMed Clinical Research
Las Vegas, Nevada, United States
Northern New Jersey Eye Institut PA
South Orange, New Jersey, United States
Cornerstone Eye Care
High Point, North Carolina, United States
Eye Care Assoc of Greater Cincinnati Inc
Cincinnati, Ohio, United States
Abrams Eye Center
Cleveland, Ohio, United States
Apex Eye Clinical Reserach
Mason, Ohio, United States
Scott Christie Eye Care Associates
Cranberry Township, Pennsylvania, United States
Bucci Laser Vision Institute
Wilkes-Barre Township, Pennsylvania, United States
Vance Thompson Vision Hospital
Sioux Falls, South Dakota, United States
Chattanooga Eye Institute
Chattanooga, Tennessee, United States
University Eye Specialists
Maryville, Tennessee, United States
Total Eye Care PA
Memphis, Tennessee, United States
Toyos Clinic
Nashville, Tennessee, United States
Advancing Vision Research LLC
Smyrna, Tennessee, United States
Texan Eye P A
Austin, Texas, United States
Intouch Clinical Research Center
Houston, Texas, United States
Neuro Eye Clinical Trials Inc
Houston, Texas, United States
Revolution Research
Lakeway, Texas, United States
Parkhurst NuVision
San Antonio, Texas, United States
Stacy R Smith MD PC
Salt Lake City, Utah, United States
Southern Utah Medical Research
St. George, Utah, United States
Piedmont Eye Center
Lynchburg, Virginia, United States
Virginia Eye Consultants
Norfolk, Virginia, United States
Periman Eye Institute
Seattle, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CECF843A2201
Identifier Type: -
Identifier Source: org_study_id
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