PMCF Study to Evaluate Performance and Safety of "CLHA-based Eyedrops" Used to Improve Lacrimal Abnormalities
Dry Eye Disease, Dry Eye, Kerato Conjunctivitis Sicca
About this trial
This is an interventional treatment trial for Dry Eye Disease
Eligibility Criteria
Inclusion Criteria: Patient Informed consent form (ICF) signed; Male and Female Aged ≥ 18 years at the time of the signature of the ICF; Patients with dry eye symptoms and/or redness, fatigue, discomfort of the eye or the ocular mucosa due to intrinsic or extrinsic factors such as atmospheric agents, environmental factors, inflammation, blepharitis, eye surgery, and/or use of contact lenses; 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 Investigational Product (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.
Sites / Locations
- Azienda Ospedaliero-Universitaria Policlinico "G.Rodolico - San Marco"Recruiting
Arms of the Study
Arm 1
Experimental
Eyedrops treatment arm