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

Novartis

Status and phase: Completed; Phase 2

Conditions: Dry Eye

Treatments: Other: ECF843 vehicle; Drug: ECF843

Study type: Interventional

Funder types: Industry

Identifiers

NCT04391894

CECF843A2201

Details and patient eligibility

About

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.

Full description

Part 1 of the study was a double-masked, randomized, parallel design in which participants were assigned to one of the following five treatment arms/groups in a ratio of 1:1:1:1:1.

• ECF843 0.45 mg/mL three times daily (TID) or vehicle
• ECF843 0.15 mg/mL TID or vehicle
• ECF843 vehicle TID
• ECF843 0.15 mg/mL twice daily (BID) or vehicle
• ECF843 vehicle BID The planned duration of double-masked treatment during Part 1 was 56 days. For subjects randomized to ECF843, the maximum drug exposure was up to 28 days. At some point during Part 1, all participants received vehicle.

The study was terminated after completion of Part 1 and Part 2 of the study was not therefore initiated.

Enrollment: 558 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 organ system within the past five years
• Pregnant or nursing women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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558 participants in 5 patient groups, including a placebo group

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

Experimental group

Description:

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

Treatment:

Drug: ECF843

Other: ECF843 vehicle

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

Experimental group

Description:

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

Treatment:

Drug: ECF843

Other: ECF843 vehicle

ECF843 vehicle TID (Part 1)

Placebo Comparator group

Description:

ECF843 vehicle TID (Part 1)

Treatment:

Other: ECF843 vehicle

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

Experimental group

Description:

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

Treatment:

Drug: ECF843

Other: ECF843 vehicle

ECF843 vehicle BID (Part 1)

Placebo Comparator group

Description:

ECF843 vehicle BID (Part 1)

Treatment:

Other: ECF843 vehicle