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 @ 2:42 AM
Ignite Modification Date:
2025-12-25 @ 2:42 AM
NCT ID:
NCT04485533
Eligibility Criteria:
Inclusion Criteria:
* Patient Informed consent form (ICF) signed.
* Males and Females aged ≥18 years at the time of the signature of ICF.
* Patients with moderate dry eye disease (DED) according to IDEEL questionnaire (score ≥51 and ≤64) and diagnosed at least 3 months before enrolment.
* No use of other tear substitutes in the 5 days prior to enrolment, except for refresh solutions.
* TBUT value \<6 sec.
* Willing to follow all study procedures, including attending all site visits, tests and examinations.
* Women must agree to be using two forms of effective contraception, be post-menopausal from at least 12 months prior to trial entry, or surgically sterile.
Exclusion Criteria:
* Patients with a mild or severe dry eye disease (DED) according to IDEEL questionnaire (score ≤50 and ≥65, respectively).
* Use of ophthalmologic products in the 14 days prior to enrolment, except for refresh solutions and stable glaucoma treatment.
* No previous history or presence of any disease involving cornea or conjunctiva.
* Sjӧgren syndrome.
* History or active cicatricial conjunctivitis.
* History of ocular surface burns.
* Use of contact lenses.
* Corneal refractive surgery 1 year post-operative.
* Any ocular surgery in the previous 3 months preceding the study.
* Unstable glaucoma (treatment changes in the last year).
* Any macular or retinal disease that could impact visual acuity.
* Best corrected visual acuity (BCVA) below 20/40.
* Blepharitis treatment started less than 3 months before enrolment.
* Neurological, neurodegenerative or cerebrovascular conditions.
* Any clinically significant history of serious digestive tract, liver, kidney, cardiovascular, cancer or hematological disease.
* Unstable treatment with systemic medications, such as diuretics, antihistamines, antidepressants, psychotropics, cholesterol lowering agents and beta-blockers.
* Known hypersensitivity to one of the administered products.
* Known drug and/or alcohol abuse.
* Mental incapacity that precludes adequate understanding or cooperation.
* Participation in another investigational study or blood donation within 1 month prior to ICF signature.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04485533
Study Brief:
Protocol Section:
NCT04485533