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

Completed · Phase 2

Conditions studied: Dry Eye

In brief

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.

Key facts

Study ID

NCT04391894

Run by

Novartis Pharmaceuticals

People needed

718

Starts

2020-10-06

Expected to finish

2021-05-13

Last updated by the study team

2025-01-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 must have dry eye

You may not qualify if…

• 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
• 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

Where it is running

• 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
• Arizona Eye Center — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.