A Study to Assess the Safety and Efficacy of ECF843 vs Vehicle in Subjects With Dry Eye Disease (NCT04391894) | Clinical Trial Compass
CompletedPhase 2
A Study to Assess the Safety and Efficacy of ECF843 vs Vehicle in Subjects With Dry Eye Disease
United States718 participantsStarted 2020-10-06
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 withi…
What they're measuring
1
Part 1: Change From Baseline in Symptom Assessment in Dry Eye (SANDE) Score
Timeframe: Up to 28 days (Baseline (BL) to end of randomized treatment)
2
Part 1: Change From Baseline in Composite Corneal Fluorescein Staining Score
Timeframe: Up to 28 days (Baseline (BL) to end of randomized treatment)