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 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT01548833
Eligibility Criteria:
Inclusion Criteria:
* Be of legal age of consent and sign written Informed Consent document, or if under legal age, have written consent of parent or guardian to participate.
* Require vision correction in both eyes.
* Wear either daily disposable contact lenses or weekly/monthly replacement contact lenses in powers between -0.50 and -10.00 diopters, cylinder ≤0.75 diopter, no ADD correction.
* Wear habitual contact lenses an average of 12-14 hours per day, at least 5 days per week.
* Willing and able to wear study contact lenses 16 hours per day.
* Able to achieve visual acuity of at least 6/7.5 in each eye with study lenses.
* Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
* Currently wearing DAILIES TOTAL1®, 1-DAY ACUVUE® TRUEYE™, or Clariti™ 1day contact lenses.
* Require monovision correction.
* Any systemic or ocular disease or disorder (refractive disorder allowed and dry eye permitted), complicating factors, or structural abnormality that would negatively affect the conduct or outcome of the study.
* Ocular surgery/trauma within the last 6 months.
* Topical or systemic antibiotic use within 7 days of enrollment.
* Topical ocular or systemic corticosteroid use within 14 days of enrollment.
* Pregnant and nursing women.
* Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollment.
* Other protocol-defined exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01548833
Study Brief:
Protocol Section:
NCT01548833