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

Last Update: Dec 22, 2020

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