Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT04391894
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04391894
Study Brief:
Protocol Section:
NCT04391894