Largo, Florida 33773

  • Dry Eye

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.


Study summary:

The study will be conducted in 2 parts: Part 1 - efficacy and safety of ECF843 vs vehicle, followed by Part 2 - exploratory assessment of ECF843 vs 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.


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


NCT ID:

NCT04391894


Primary Contact:

Study Director
Novartis Pharmaceuticals
Novartis Pharmaceuticals

Novartis Pharmaceuticals
Phone: 1-888-669-6682
Email: novartis.email@novartis.com


Backup Contact:

Novartis Pharmaceuticals


Location Contact:

Largo, Florida 33773
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 28, 2021

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