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 @ 3:51 PM
Ignite Modification Date:
2025-12-24 @ 3:51 PM
NCT ID:
NCT00885092
Eligibility Criteria:
Inclusion Criteria:
* 18 years of age or older.
* Must be successfully wearing assigned study lens brand (either ACUVUE® OASYS™ or PureVision® contact lenses) for at least 7-10 days, minimum 8 hours a day, prior to Visit 1 (screening).
* Vision correctable to 20/30 (Snellen) or better in each eye at distance with study lenses at Visit 1 (screening).
* Must have discontinued contact lens wear for at least two consecutive days before Visit 2 (baseline).
* Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
* Any medical condition (systemic or ophthalmic) that may, in the opinion of the investigator, preclude safe administration of test article or safe participation in the study.
* Known sensitivity or intolerance to any protocol-specified contact lens solutions, eye drops, or products containing similar ingredients (e.g., generic products).
* Monocular vision (only one eye with functional vision) or fit with only one contact lens.
* Use of topical ocular over-the-counter or prescribed topical ocular medication, with the exception of rewetting drops, within 7 days prior to screening visit.
* Current or history of ocular infection, inflammation, disease, structural abnormality or conditions within the last 6 months that could affect study participation or may preclude safe administration of the investigational lens care solution, in the opinion of the investigator.
* Any corneal surgery, cataract surgery, intraocular lens implants or glaucoma filtering surgery within the last 12 months.
* Any slit-lamp finding score of 1 (or rated 3 or 4 for limbal and bulbar conjunctival injection) at screening or baseline visits.
* Corneal staining area assessment ≥ 20% in any corneal region in either eye at screening or baseline visit.
* Corneal staining graded as 2 (macropunctate) or greater in any corneal region in either eye at baseline visit.
* Participation in any investigational clinical study within 30 days of baseline visit.
* Other protocol-defined exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00885092
Study Brief:
Protocol Section:
NCT00885092