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 @ 9:34 PM
Ignite Modification Date:
2025-12-24 @ 9:34 PM
NCT ID:
NCT03519932
Eligibility Criteria:
Inclusion Criteria:
* Is at least 17 years of age and has full legal capacity to volunteer;
* Has had a self-reported oculo-visual examination in the last two years.
* Has read and signed an information consent letter;
* Is willing and able to follow instructions and maintain the appointment schedule;
* Is an adapted soft contact lens wearer, who currently wears contact lenses for a minimum 3 days/week and 8 hours/day AND who anticipates no difficulty wearing CLs for 6 days/week, 10 hours /day.
* Is willing to wear contact lens in both eyes for the duration of the study;
* Has a minimum astigmatism of - 0.75, determined by refraction;
* Can be fit with the two study contact lens types in the powers available;
* Has a distance visual acuity of 0.20 logMAR (approx 20/30) or better, determined by refraction;
* Can achieve a distance visual acuity of 0.20 logMAR (approx 20/30) or better in each eye with the study contact lenses.
* Has clear corneas and no active\* ocular disease
Exclusion Criteria:
* Is participating in any concurrent clinical trial;
* Has any known active\* ocular disease and/or infection;
* Has a systemic condition that in the opinion of the investigator may affect a study measure;
* Is using any systemic or topical medications that in the opinion of the investigator may affect a study measure;
* Has known sensitivity to fluorescein dye or products to be used in the study;
* Appears to have any active\* ocular pathology, ocular anomaly or severe insufficiency of lacrimal secretion (severe dry eye) that would affect the wearing of contact lenses;
* Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
* Is aphakic;
* Has undergone refractive error surgery.
* Has participated in the PIANO (i.e. EX-MKTG-83) Study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
17 Years
Study:
NCT03519932
Study Brief:
Protocol Section:
NCT03519932