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 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
NCT ID:
NCT02506257
Eligibility Criteria:
Inclusion Criteria:
* able and willing to give informed consent.
* man or woman of any race and 18 to 55 years of age, inclusive.
* Body Mass Index of 20-30 kg/m2
* willing and able to attend required study visits.
* bilateral visual acuity \>6/10.
* intraocular pressure (IOP) of 14-21 mmHg.
* ophthalmologic examination without abnormalities.
* medical history without major pathology.
* laboratory test results without deviations from the normal range.
* female subjects of childbearing potential with negative urine pregnancy test and using effective contraception during the study.
Exclusion Criteria:
* presence of bacterial ocular infections.
* presence of any concomitant ocular pathology.
* performing activities likely to result in an irritated conjunctiva during the study (including heavy alcohol intake, swimming in chlorinated water and heavy smoking).
* contact lenses wearing .
* ocular surface fluorescein staining score \>3.
* use of topical or systemic antibiotics, antihistamines, decongestants and non-steroidal anti-inflammatory agents as well as steroids within 7 days before screening.
* known or suspected allergy to biguanides or intolerance to any other ingredient of the test treatments.
* ocular surgery performed within 12 months before screening.
* participation in another clinical study in the preceding 30 days.
* one functional eye.
* pregnancy or breastfeeding.
* use of recreational drugs.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT02506257
Study Brief:
Protocol Section:
NCT02506257