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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04391894
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Novartis Pharmaceuticals
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Novartis Pharmaceuticals
Principal Investigator Affiliation Novartis Pharmaceuticals
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Dry Eye
Additional Details

The study will be conducted in 2 parts: Part 1

  • - efficacy and safety of ECF843 vs.#46;vehicle, followed by Part 2 - exploratory assessment of ECF843 vs.#46;Xiidra®.
Part 1 uses a double-masked design where subjects will be randomized to receive BID or TID treatment with either ECF843 or vehicle for 56 days. Part 2 will be initiated only if safety and efficacy of ECF843 during Part 1 is demonstrated. Part 2 uses an open-label design of ECF843 versus Xiidra® for 84 days after a 2-week vehicle run-in phase. Approximately 800 subjects will need to be screened in Part 1 to have approximately 680 subjects randomized into the 56-day treatment period. For Part 2, it is estimated that up to 200 subjects will need to be screened to randomize up to 160 subjects into the 2 treatment arms.

Arms & Interventions

Arms

Experimental: ECF843 0.45 mg/mL TID or vehicle (Part 1)

Randomized to a 1:1:1:1:1 ratio in Part 1. Topical ocular eye drops.

Experimental: ECF843 0.15 mg/mL TID or vehicle (Part 1)

Randomized to a 1:1:1:1:1 ratio in Part 1. Topical ocular eye drops.

Placebo Comparator: ECF843 vehicle TID (Part 1)

Randomized to a 1:1:1:1:1 ratio in Part 1. Topical ocular eye drops.

Experimental: ECF843 0.15 mg/mL BID or vehicle (Part 1)

Randomized to a 1:1:1:1:1 ratio in Part 1. Topical ocular eye drops.

Placebo Comparator: ECF843 vehicle BID (Part 1)

Randomized to a 1:1:1:1:1 ratio in Part 1. Topical ocular eye drops.

Experimental: ECF843 -Part 2 (concentration/frequency TBD from Part 1)

Randomized in a 1:1 ratio in Part 2. Topical ocular eye drops. Exploratory Arm only.

Active Comparator: Xiidra® -Part 2 (5% lifitegrast BID)

Randomized in a 1:1 ratio in Part 2. Topical ocular eye drops. Exploratory Arm only.

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)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Novartis Investigative Site, Chandler, Arizona

Status

Active, not recruiting

Address

Novartis Investigative Site

Chandler, Arizona, 85224

Novartis Investigative Site, Mesa, Arizona

Status

Active, not recruiting

Address

Novartis Investigative Site

Mesa, Arizona, 85202

Novartis Investigative Site, Phoenix, Arizona

Status

Active, not recruiting

Address

Novartis Investigative Site

Phoenix, Arizona, 85032

Novartis Investigative Site, Azusa, California

Status

Active, not recruiting

Address

Novartis Investigative Site

Azusa, California, 91702

Novartis Investigative Site, Garden Grove, California

Status

Recruiting

Address

Novartis Investigative Site

Garden Grove, California, 92843

Novartis Investigative Site, Glendale, California

Status

Active, not recruiting

Address

Novartis Investigative Site

Glendale, California, 91203

Novartis Investigative Site, Glendale, California

Status

Active, not recruiting

Address

Novartis Investigative Site

Glendale, California, 91205

Novartis Investigative Site, Inglewood, California

Status

Recruiting

Address

Novartis Investigative Site

Inglewood, California, 90301

Novartis Investigative Site, Laguna Hills, California

Status

Active, not recruiting

Address

Novartis Investigative Site

Laguna Hills, California, 92653

Novartis Investigative Site, Mission Hills, California

Status

Active, not recruiting

Address

Novartis Investigative Site

Mission Hills, California, 91345

Novartis Investigative Site, Newport Beach, California

Status

Active, not recruiting

Address

Novartis Investigative Site

Newport Beach, California, 92663

Novartis Investigative Site, Petaluma, California

Status

Active, not recruiting

Address

Novartis Investigative Site

Petaluma, California, 94954

Novartis Investigative Site, Rancho Cordova, California

Status

Active, not recruiting

Address

Novartis Investigative Site

Rancho Cordova, California, 95670

Novartis Investigative Site, Santa Ana, California

Status

Active, not recruiting

Address

Novartis Investigative Site

Santa Ana, California, 92705

Novartis Investigative Site, Colorado Springs, Colorado

Status

Completed

Address

Novartis Investigative Site

Colorado Springs, Colorado, 80907

Novartis Investigative Site, Coral Springs, Florida

Status

Recruiting

Address

Novartis Investigative Site

Coral Springs, Florida, 33067

Novartis Investigative Site, Deerfield Beach, Florida

Status

Recruiting

Address

Novartis Investigative Site

Deerfield Beach, Florida, 33064

Novartis Investigative Site, Fort Lauderdale, Florida

Status

Recruiting

Address

Novartis Investigative Site

Fort Lauderdale, Florida, 33309

Novartis Investigative Site, Fort Myers, Florida

Status

Recruiting

Address

Novartis Investigative Site

Fort Myers, Florida, 33901

Novartis Investigative Site, Largo, Florida

Status

Recruiting

Address

Novartis Investigative Site

Largo, Florida, 33773

Novartis Investigative Site, Mount Dora, Florida

Status

Recruiting

Address

Novartis Investigative Site

Mount Dora, Florida, 32757

Novartis Investigative Site, Indianapolis, Indiana

Status

Withdrawn

Address

Novartis Investigative Site

Indianapolis, Indiana, 46290

Novartis Investigative Site, Pittsburg, Kansas

Status

Completed

Address

Novartis Investigative Site

Pittsburg, Kansas, 66762

Novartis Investigative Site, Louisville, Kentucky

Status

Recruiting

Address

Novartis Investigative Site

Louisville, Kentucky, 40206

Novartis Investigative Site, Boston, Massachusetts

Status

Recruiting

Address

Novartis Investigative Site

Boston, Massachusetts, 02111

Novartis Investigative Site, Kansas City, Missouri

Status

Active, not recruiting

Address

Novartis Investigative Site

Kansas City, Missouri, 64133

Novartis Investigative Site, Kansas City, Missouri

Status

Completed

Address

Novartis Investigative Site

Kansas City, Missouri, 64154

Novartis Investigative Site, Saint Louis, Missouri

Status

Recruiting

Address

Novartis Investigative Site

Saint Louis, Missouri, 63128

Novartis Investigative Site, Springfield, Missouri

Status

Recruiting

Address

Novartis Investigative Site

Springfield, Missouri, 65807

Novartis Investigative Site, Washington, Missouri

Status

Active, not recruiting

Address

Novartis Investigative Site

Washington, Missouri, 63090

Novartis Investigative Site, Henderson, Nevada

Status

Active, not recruiting

Address

Novartis Investigative Site

Henderson, Nevada, 89052

Novartis Investigative Site, Las Vegas, Nevada

Status

Completed

Address

Novartis Investigative Site

Las Vegas, Nevada, 89123

Novartis Investigative Site, South Orange, New Jersey

Status

Active, not recruiting

Address

Novartis Investigative Site

South Orange, New Jersey, 07079

Novartis Investigative Site, Durham, North Carolina

Status

Recruiting

Address

Novartis Investigative Site

Durham, North Carolina, 27710

Novartis Investigative Site, High Point, North Carolina

Status

Recruiting

Address

Novartis Investigative Site

High Point, North Carolina, 27262

Novartis Investigative Site, Cincinnati, Ohio

Status

Active, not recruiting

Address

Novartis Investigative Site

Cincinnati, Ohio, 45236

Novartis Investigative Site, Cleveland, Ohio

Status

Recruiting

Address

Novartis Investigative Site

Cleveland, Ohio, 44115

Novartis Investigative Site, Mason, Ohio

Status

Recruiting

Address

Novartis Investigative Site

Mason, Ohio, 45040

Novartis Investigative Site, Cranberry Township, Pennsylvania

Status

Recruiting

Address

Novartis Investigative Site

Cranberry Township, Pennsylvania, 16066

Novartis Investigative Site, Wilkes-Barre Township, Pennsylvania

Status

Recruiting

Address

Novartis Investigative Site

Wilkes-Barre Township, Pennsylvania, 18702

Novartis Investigative Site, Sioux Falls, South Dakota

Status

Active, not recruiting

Address

Novartis Investigative Site

Sioux Falls, South Dakota, 57108

Novartis Investigative Site, Chattanooga, Tennessee

Status

Recruiting

Address

Novartis Investigative Site

Chattanooga, Tennessee, 37411

Novartis Investigative Site, Maryville, Tennessee

Status

Recruiting

Address

Novartis Investigative Site

Maryville, Tennessee, 37803

Novartis Investigative Site, Memphis, Tennessee

Status

Recruiting

Address

Novartis Investigative Site

Memphis, Tennessee, 38119

Novartis Investigative Site, Nashville, Tennessee

Status

Recruiting

Address

Novartis Investigative Site

Nashville, Tennessee, 37205

Novartis Investigative Site, Nashville, Tennessee

Status

Recruiting

Address

Novartis Investigative Site

Nashville, Tennessee, 37215

Novartis Investigative Site, Smyrna, Tennessee

Status

Recruiting

Address

Novartis Investigative Site

Smyrna, Tennessee, 37167

Novartis Investigative Site, Austin, Texas

Status

Active, not recruiting

Address

Novartis Investigative Site

Austin, Texas, 78731

Novartis Investigative Site, Bellaire, Texas

Status

Active, not recruiting

Address

Novartis Investigative Site

Bellaire, Texas, 77401

Novartis Investigative Site, Houston, Texas

Status

Recruiting

Address

Novartis Investigative Site

Houston, Texas, 77030

Novartis Investigative Site, Houston, Texas

Status

Active, not recruiting

Address

Novartis Investigative Site

Houston, Texas, 77034

Novartis Investigative Site, Lakeway, Texas

Status

Active, not recruiting

Address

Novartis Investigative Site

Lakeway, Texas, 78738

Novartis Investigative Site, San Antonio, Texas

Status

Active, not recruiting

Address

Novartis Investigative Site

San Antonio, Texas, 78229

Novartis Investigative Site, Saint George, Utah

Status

Active, not recruiting

Address

Novartis Investigative Site

Saint George, Utah, 84790

Novartis Investigative Site, Salt Lake City, Utah

Status

Active, not recruiting

Address

Novartis Investigative Site

Salt Lake City, Utah, 84117

Novartis Investigative Site, Lynchburg, Virginia

Status

Recruiting

Address

Novartis Investigative Site

Lynchburg, Virginia, 24502

Novartis Investigative Site, Norfolk, Virginia

Status

Recruiting

Address

Novartis Investigative Site

Norfolk, Virginia, 23502

Novartis Investigative Site, Seattle, Washington

Status

Active, not recruiting

Address

Novartis Investigative Site

Seattle, Washington, 98119