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

Dry Eye Clinical Trial

Official title:

A Randomized, Double-masked, Multicenter Study to Evaluate the Safety and Efficacy of ECF843 vs Vehicle in Subjects With Dry Eye Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04391894
• Other study ID #: CECF843A2201
• Status: Completed
• Phase: Phase 2
• Start date: October 6, 2020
• Est. completion date: May 13, 2021

Study information

• Verified date: January 2023
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 558
• Est. completion date: May 13, 2021
• Est. primary completion date: May 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• ECF843
Topical ocular eye drop

Other:
• ECF843 vehicle
Topical ocular eye drop

Locations

Country	Name	City	State
United States	Novartis Investigative Site	Austin	Texas
United States	Novartis Investigative Site	Azusa	California
United States	Novartis Investigative Site	Bellaire	Texas
United States	Novartis Investigative Site	Boston	Massachusetts
United States	Novartis Investigative Site	Chandler	Arizona
United States	Novartis Investigative Site	Chattanooga	Tennessee
United States	Novartis Investigative Site	Cincinnati	Ohio
United States	Novartis Investigative Site	Cleveland	Ohio
United States	Novartis Investigative Site	Colorado Springs	Colorado
United States	Novartis Investigative Site	Coral Springs	Florida
United States	Novartis Investigative Site	Cranberry Township	Pennsylvania
United States	Novartis Investigative Site	Fort Lauderdale	Florida
United States	Novartis Investigative Site	Fort Myers	Florida
United States	Novartis Investigative Site	Garden Grove	California
United States	Novartis Investigative Site	Glendale	California
United States	Novartis Investigative Site	Glendale	California
United States	Novartis Investigative Site	Henderson	Nevada
United States	Novartis Investigative Site	High Point	North Carolina
United States	Novartis Investigative Site	Houston	Texas
United States	Novartis Investigative Site	Inglewood	California
United States	Novartis Investigative Site	Kansas City	Missouri
United States	Novartis Investigative Site	Kansas City	Missouri
United States	Novartis Investigative Site	Laguna Hills	California
United States	Novartis Investigative Site	Lakeway	Texas
United States	Novartis Investigative Site	Largo	Florida
United States	Novartis Investigative Site	Las Vegas	Nevada
United States	Novartis Investigative Site	Louisville	Kentucky
United States	Novartis Investigative Site	Lynchburg	Virginia
United States	Novartis Investigative Site	Maryville	Tennessee
United States	Novartis Investigative Site	Mason	Ohio
United States	Novartis Investigative Site	Memphis	Tennessee
United States	Novartis Investigative Site	Mesa	Arizona
United States	Novartis Investigative Site	Mission Hills	California
United States	Novartis Investigative Site	Mount Dora	Florida
United States	Novartis Investigative Site	Nashville	Tennessee
United States	Novartis Investigative Site	Newport Beach	California
United States	Novartis Investigative Site	Norfolk	Virginia
United States	Novartis Investigative Site	Petaluma	California
United States	Novartis Investigative Site	Phoenix	Arizona
United States	Novartis Investigative Site	Pittsburg	Kansas
United States	Novartis Investigative Site	Rancho Cordova	California
United States	Novartis Investigative Site	Saint George	Utah
United States	Novartis Investigative Site	Saint Louis	Missouri
United States	Novartis Investigative Site	Salt Lake City	Utah
United States	Novartis Investigative Site	San Antonio	Texas
United States	Novartis Investigative Site	Santa Ana	California
United States	Novartis Investigative Site	Seattle	Washington
United States	Novartis Investigative Site	Sioux Falls	South Dakota
United States	Novartis Investigative Site	Smyrna	Tennessee
United States	Novartis Investigative Site	South Orange	New Jersey
United States	Novartis Investigative Site	Washington	Missouri
United States	Novartis Investigative Site	Wilkes-Barre Township	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 1: Change From Baseline in Symptom Assessment in Dry Eye (SANDE) Score	The SANDE uses a 100 mm visual analog scale (VAS) and asks the subject to score frequency and severity of their ocular discomfort over the past 24 hours by putting a vertical mark on two separate horizontal scoring lines. The frequency scoring line utilizes the anchors of 'Rarely' to 'All the Time', while the severity scoring line utilizes the anchors of 'Very Mildly' to 'Very Severely uncomfortable'. The SANDE questionnaire was completed through an electronic diary by the subject at the Screening Visit(s) of Part 1, and thereafter every evening before bedtime during the study. The overall SANDE score was calculated by taking the square root of the product of the frequency of symptoms score and the severity of symptoms score. The SANDE scale ranged from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms. Negative change from baseline indicates improvement.	Up to 28 days (Baseline (BL) to end of randomized treatment)
Primary	Part 1: Change From Baseline in Composite Corneal Fluorescein Staining Score	The degree of staining was based on the Corneal Fluorescein Modified NEI Scale. Each of the five regions (central (C), superior (S), inferior (I), temporal (T), and nasal (N)) were graded based on a scale of 0 to 4, with higher scores suggestive of higher degrees of corneal staining. After entry of the scores per region, the total or composite (sum) score for each eye was automatically calculated (maximum score = 20/eye). A (+1) was added to the sum score for any eye with the presence of filaments.	Up to 28 days (Baseline (BL) to end of randomized treatment)
Secondary	Part 1: Change From Baseline in Central Corneal Fluorescein Staining	The degree of staining was based on the Corneal Fluorescein Modified NEI Scale. Central region was graded based on a scale of 0 to 4, with higher scores suggestive of higher degrees of corneal staining.	Up to 28 days (Baseline (BL) to end of randomized treatment)
Secondary	Part 1: Change From Baseline in Inferior Corneal Fluorescein Staining	The degree of staining was based on the Corneal Fluorescein Modified NEI Scale. Inferior region was graded based on a scale of 0 to 4, with higher scores suggestive of higher degrees of corneal staining.	Up to 28 days (Baseline (BL) to end of randomized treatment)
Secondary	Part 1: Percentage of Participants With Ocular and Non-ocular Treatment Emergent Adverse Events (AEs)	The number of treatment emergent ocular and non-ocular adverse events was reported categorically: Mild, Moderate, Severe.; Treatment emergent adverse events (TEAEs) are adverse events started after the first administration of randomized study treatment or events present prior to start of the randomized treatment but increased in severity based on preferred term.	Up to 28 days (Baseline (BL) to end of randomized treatment)

External Links

•   A Plain Language Trial Summary is available on novctrd.com