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:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-24 @ 10:46 PM
NCT ID:
NCT06159569
Eligibility Criteria:
Inclusion Criteria:
* Patients of both genders aged 18-75;
* Patients with clinically diagnosed mild to moderate dry eye syndrome based on Ocular Surface Disesae Index OSDI questionnaire (Italian version) and medical examination;
* Patients with at least two signs and/or symptoms of ocular discomfort;
* Patients with good eyelid mobility;
* Patients must be able to attend the visits scheduled in the study protocol and to follow the instructions given by the Investigator;
* Patients must be able to fill in their diary at home;
* Patients who have given their written informed consent.
Exclusion Criteria:
* Ocular hypertension (\>21 mmHg) or glaucoma with/without alterations of the field of vision;
* Presence of any other eye acute conditions different from eye dry (e.g. acute ulcerative keratitis; acute purulent ophthalmia; ocular tuberculosis; ocular mycosis);
* Eye inflammation or acute eye infection within 3 months before the enrolment;
* Eye surgery within 1 year before enrolment or LASIK at any time before enrolment;
* Known hypersensitivity to any of the components of the devices used in this study;
* Concomitant use of any other eye drop;
* Concomitant use of any local or systemic treatment for dry eye;
* Concomitant use of products with known corneal toxicity and/or steroids, NSAID, or anti-glaucoma drugs;
* Concomitant hormonal therapy;
* Concomitant autoimmune inflammatory diseases or diabetes mellitus;
* Current or past participation in any other clinical trial which has ended less than a month before the enrolment;
* Use of hard contact lenses;
* Patients unlikely to cooperate in the clinical investigation or to comply with the treatment or with the clinical investigation visits.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06159569
Study Brief:
Protocol Section:
NCT06159569