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 @ 2:39 PM
Ignite Modification Date:
2025-12-24 @ 2:39 PM
NCT ID:
NCT01634659
Eligibility Criteria:
Inclusion Criteria:
* Sign written Informed Consent Document and HIPAA form.
* Be current weekly/monthly replacement contact lens wearer.
* Be willing to not sleep in contact lenses during the study period.
* Require vision correction in both eyes, with a contact lens prescription in protocol-specified power range.
* Have best corrected visual acuity of at least 20/25 in each eye.
* Be willing to wear study lenses for at least 8 hours/day and at least 5 days/week.
* Use re-wetting drops less than once per day and be willing to discontinue use of rewetting drops while wearing the study contact lenses.
* Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
* Be a neophyte or current wearer of daily disposable lenses.
* Require monovision correction or use multifocal contact lenses.
* Have any systemic or ocular disease or disorder, complicating factor, or structural abnormality that would negatively affect the conduct or outcome of the study.
* Have a history of ocular surgery/trauma within the last 6 months.
* Use topical ocular or systemic antibiotics within 7 days of enrollment.
* Use topical ocular or systemic corticosteroids within 14 days of enrollment, continuing throughout the study.
* Have participated in any other ophthalmic drug or device clinical trial within 30 days of enrollment.
* Have habitually worn contact lenses on an extended wear basis (sleeping in habitual contact lenses for at least 2 nights per week) in the last 3 months prior to enrollment.
* Use re-wetting drops once or more per day.
* Other protocol-defined exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01634659
Study Brief:
Protocol Section:
NCT01634659