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 @ 2:51 AM
Ignite Modification Date:
2025-12-25 @ 2:51 AM
NCT ID:
NCT02413333
Eligibility Criteria:
Inclusion Criteria:
* Sign informed consent form;
* Adapted, 2-week/monthly replacement silicone hydrogel contact lens wearers (at least 2 months);
* Willing to wear study lenses daily wear only on a daily basis (7 days per week and at least 4 hours per day) and attend all study visits;
* Symptoms of contact lens related dryness as defined by the Symptomatic Pre-Screening Questionnaire;
* Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
* Current hydrogen peroxide-based solution user;
* Routinely sleeps in lenses at least 1 night per week over the last 3 months prior to enrollment;
* Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
* Any systemic diseases that may affect the eye or be exacerbated by use of contact lenses or contact lens solutions or which could prevent wearing lenses at least 4 hours per day;
* Use of systemic or ocular medications for which contact lens wear could be contraindicated;
* Monocular (only 1 eye with functional vision) or fit with only 1 lens;
* History of herpetic keratitis, ocular surgery, or irregular cornea;
* Other protocol-specified exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02413333
Study Brief:
Protocol Section:
NCT02413333