Phase 2
Completed N=558
A Study to Assess the Safety and Efficacy of ECF843 vs Vehicle in Subjects With Dry Eye Disease
Source: ClinicalTrials.gov NCT04391894 ↗Enrolled (actual)
558
Serious AEs
0.4%
Results posted
May 2022
Primary outcomePrimary: Part 1: Change From Baseline in Symptom Assessment in Dry Eye (SANDE) Score — -6.0; -8.1; -4.9; -1.8 Score on scale — p=0.585
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part 1: Change From Baseline in Symptom Assessment in Dry Eye (SANDE) Score |
-6.0; -8.1; -4.9; -1.8; -6.1 | 0.585 |
| PRIMARY Part 1: Change From Baseline in Composite Corneal Fluorescein Staining Score |
-1.1; -1.0; -0.9; -1.0; -1.1 | 0.605 |
| SECONDARY Part 1: Change From Baseline in Central Corneal Fluorescein Staining |
-0.2; -0.3; -0.2; -0.2; -0.2 | — |
| SECONDARY Part 1: Change From Baseline in Inferior Corneal Fluorescein Staining |
-0.2; -0.3; -0.2; -0.2; -0.6 | — |
| SECONDARY Part 1: Percentage of Participants With Ocular and Non-ocular Treatment Emergent Adverse Events (AEs) |
5; 10; 4; 2; 7; 0 | — |
Eligibility 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 organ system within the past five years
- Pregnant or nursing women
Data sourced from ClinicalTrials.gov (NCT04391894). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.