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 @ 7:00 PM
Ignite Modification Date:
2025-12-24 @ 7:00 PM
NCT ID:
NCT03524157
Eligibility Criteria:
Inclusion Criteria:
* Systemically and ophthalmologically healthy subjects
* Signed informed consent.
* Age between 18 to 40 years.
* Both genders
* Blood tests \[complete blood count (BHC), three element blood chemistry (QS) and liver function tests (PFH)\] within normal parameters
* Visual capacity 20/30 or better
Exclusion Criteria:
* Subjects with a history of hypersensitivity to any of the components of the research products.
* Subject users of topical ophthalmic medications of any pharmacological group.
* Subject users of medication by any other route of administration.
* Women who are pregnant or breastfeeding.
* Women without a history of hysterectomy, oophorectomy or hysterectomy, who do not ensure a hormonal contraceptive method or intrauterine device during the study period.
* Subjects with participation in clinical research studies 90 days prior to inclusion in the present study.
* Diagnosis of liver disease or triple the normal upper value of any of the following liver enzymes: aspartate transferase (AST), alanine transferase (ALT) or bilirubin.
* Inability to attend or answer the evaluations made in each of the visits.
* Positive smoking (specified as cigarette consumption regardless of quantity and frequency)
* Positive alcoholism (specified as the consumption of alcoholic beverages, regardless of quantity and frequency, during the study intervention period).
* Users of contact lenses.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT03524157
Study Brief:
Protocol Section:
NCT03524157