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:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07422259
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent
* Male and female, aged 18 to 80 years
* Alteration of the tear film or bilateral ocular surface discomfort resulting from one of the following conditions:
Patients receiving chronic therapy with antihypertensive eye drops; Patients receiving post-ocular surgery therapy for at least 15 days
* At least two of the following symptoms of dry eye: burning, stinging, dry eye sensation, foreign body sensation, photophobia
* At least two of the following:
Schirmer's test (8 mm lower in 5 minutes) BUT (Burning Time) less than 10 seconds Fluorescein Infection Infection (NEI) score ≥3
Exclusion Criteria:
* Active keratitis caused by herpes simplex, vaccinia virus, varicella-zoster, and other viral infections of the cornea and conjunctiva
* Current bacterial, fungal, and tuberculosis infections
* Corneal stromal perforations and ulcers
* Hypersensitivity to any of the product components
* Current ocular allergy or allergic rhinitis
* Participation in a clinical trial in the month prior to the start of the study
* Systemic anti-acne therapy in the 6 months prior to the start of the study
* Any change in systemic therapy in the month prior to the start of the study
* Contact lens use in the week prior to the start of the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07422259
Study Brief:
Protocol Section:
NCT07422259