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 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT05807360
Eligibility Criteria:
Inclusion Criteria:
* Patient Informed consent form (ICF) signed;
* Male \& Female Aged ≥ 18 years at the time of the signature of the ICF;
* Patients with ophthalmic discomfort due to dry eye for intrinsic and/or extrinsic causes, contact lenses wearing and/or eye surgery;
* WIlling not to use other eye drops during the entire treatment period.
Exclusion Criteria:
* Other - different - eyes clinical conditions (e.g. glaucoma);
* Suspected alcohol or drug abuse;
* Known hypersensitivity or allergy to IP components;
* Other clinically significant and uncontrolled pathologies that may interfere with study results (e.g. rheumatic diseases, diabetes);
* Participation in another investigational study;
* Inability to follow all study procedures, including attending all site visits, tests and examinations;
* Mental incapacity that precludes adequate understanding or cooperation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05807360
Study Brief:
Protocol Section:
NCT05807360