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

• Status: Completed
• Trial end date: 2021-05-25
• Target enrollment: 0
• Participant gender: All

Summary

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 topical ocular vehicle for the treatment of subjects with dry eye disease.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Lifitegrast

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 must have dry eye

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

• 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 organs system

• Pregnant or nursing women