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 @ 2:05 AM
Ignite Modification Date:
2025-12-25 @ 2:05 AM
NCT ID:
NCT01682460
Eligibility Criteria:
Inclusion Criteria:
* At least 17 years of age and has full legal capacity to volunteer;
* Has read and signed an information consent letter;
* Is willing and able to follow instructions and maintain the appointment schedule;
* Is a current non-contact lens wearer.
* Has previously been diagnosed with primary open angle glaucoma and is currently being treated with a topical therapeutic agent.
* The glaucoma medication dosage and usage must have been the same for \>6 months.
* Shows a minimum score of 2 (sometimes) on the SESOD questionnaire.
* Distance VA of at least 20/40 in each eye with current spectacle correction.
Exclusion Criteria:
* Is participating in any concurrent clinical or research study;
* Has any known active\* ocular disease and/or infection; except primary open angle glaucoma.
* Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
* Is using any systemic or topical medications (with the exception of glaucoma medication) that in the opinion of the investigator may affect a study outcome variable;
* Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
* Is pregnant, lactating or planning a pregnancy at the time of enrolment;
* Has undergone refractive error surgery;
* Is an employee of the Centre for Contact Lens Research;
* Has taken part in another (pharmaceutical) research study within the last 30 days;
* Is currently using artificial tears more than 3 times per day.
* For the purposes of this study, active ocular disease is defined as infection or inflammation that requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
17 Years
Study:
NCT01682460
Study Brief:
Protocol Section:
NCT01682460