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 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 1:22 AM
NCT ID:
NCT04195893
Eligibility Criteria:
Inclusion Criteria:
* Subjects will only be eligible for the study if:
1. Is at least 17 years of age and has full legal capacity to volunteer;
2. Has read and signed an information consent letter;
3. Is willing and able to follow instructions and maintain the appointment schedule;
4. Habitually wears silicone hydrogel frequent replacement soft contact lenses, for minimum of 6-months;
5. Is correctable to a visual acuity of 20/40 or better (in each eye) with the study lenses;
6. Can be fit with study contact lenses with a power between - 0.50 and -10.00 DS;
7. Demonstrates an acceptable fit with the study lenses;
8. Habitually wears contact lenses for at least 8 hours per day, and willing to wear contact lenses for at least 12 hours a day in the study.
Exclusion Criteria:
* Subjects will not be eligible to take part in the study if:
1. Is participating in any concurrent clinical or research study;
2. Has any known active\* ocular disease and/or infection;
3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
5. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
6. Is pregnant, lactating or planning a pregnancy at the time of enrolment (verbal confirmation at the screening visit);
7. Is aphakic;
8. Has undergone refractive error surgery;
9. Is an employee of the Centre for Ocular Research \& Education;
10. Has participated in the BEAGLE (EX-MKTG-104) study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
17 Years
Study:
NCT04195893
Study Brief:
Protocol Section:
NCT04195893