Status:
COMPLETED
A Study to Assess the Safety and Efficacy of ECF843 vs Vehicle in Subjects With Dry Eye Disease
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Dry Eye
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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. Bot...
Detailed 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/m...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 13 2021
Estimated Enrollment :
718 Patients enrolled
Trial Details
Trial ID
NCT04391894
Start Date
October 6 2020
End Date
May 13 2021
Last Update
January 28 2025
Active Locations (52)
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1
Arizona Eye Center
Chandler, Arizona, United States, 85224
2
Carrot Eye Center
Mesa, Arizona, United States, 85202
3
Phoenix Eye Care and Dry Eye Ctr
Phoenix, Arizona, United States, 85032
4
Milton Hom OD
Azusa, California, United States, 91702