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:
NCT01684033
Eligibility Criteria:
Inclusion Criteria:
* Wear single vision sphere silicone hydrogel contact lenses (CooperVision™ Biofinity®, Alcon® Air Optix® Aqua, Bausch+Lomb® PureVision™ or ACUVUE® Oasys™) on a daily wear basis (a minimum of 8 hours per day, 5 days a week) for at least one month prior to Visit 1;
* Willing to wear lenses on a daily wear basis (a minimum of 8 hours per day, 5 days a week) for the duration of the study, and wear lenses for 16 hours on two days during the study;
* Must have habitually used a Biguanide preserved multi-purpose solution (other than Biotrue) for at least 30 days prior to Visit 1;
* Vision correctable to 20/30 Snellen (feet) or better in each eye at distance with pre-study contact lenses at Visit 1;
* Have access, capability and willingness to review and answer text messages;
* Read, sign, and date IRB/IEC approved informed consent and privacy document before enrollment;
* Willing to follow the study procedures and visit schedule;
* Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
* Need to wear lenses on an extended wear (i.e. overnight) basis during the study;
* Known sensitivity or intolerance to Biguanide, polyquaternium-1 (POLYQUAD), or ALDOX preserved lens care products;
* Monocular (only one eye with functional vision) or fit with only one lens;
* Wearing toric or multifocal contact lenses or fit with monovision;
* Use of additional lens care products other than a Biguanide preserved multipurpose solution such as daily or enzyme cleaners within the one week prior to Visit 1;
* Use of topical ocular over-the-counter (OTC) or prescribed topical ocular medications, with the exception of rewetting drops, within 7 days prior to Visit 1;
* Abnormal ocular condition observed during the Visit 1 slit-lamp examination;
* Current or history of ocular infections or severe inflammation within 6 months prior to Visit 1;
* Ocular surgery within the 12 months prior to Visit 1;
* Participation in any other clinical trial within 30 days of enrollment;
* Other protocol-defined exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01684033
Study Brief:
Protocol Section:
NCT01684033