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 @ 5:32 PM
Ignite Modification Date:
2025-12-24 @ 5:32 PM
NCT ID:
NCT01912768
Eligibility Criteria:
Inclusion Criteria:
* Normal eyes (other than correction for visual acuity);
* Successful history of silicone hydrogel or soft contact lens wear in both eyes in one of the following brands: Soflens® 38, Proclear DW, Frequency 55, Acuvue® Oasys™, Air Optix Aqua, O2 OPTIX, Air Optix for Astigmatism, Air Optix Aqua Multifocal, Biofinity®, PureVision®, PureVision®2;
* Best spectacle corrected distance visual acuity greater than or equal to 20/25 in each eye;
* Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
* Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the investigational products or affect the results of this study;
* Need to wear contact lenses on an extended wear basis (ie, overnight) during the study;
* Use of a daily cleaner and/or an enzyme cleaner to care for lenses at least 7 days prior to Visit 1;
* History of intolerance or hypersensitivity to any component of the investigational products;
* Use of all over-the-counter (OTC) or prescribed topical ocular medications within 7 days prior to Visit 1;
* Moderate, severe, abnormal, or other ocular findings;
* Current or history of ocular infection, severe inflammation, or disease within 6 months prior to Visit 1;
* Any systemic disease at Visit 1 (including allergies, respiratory infections or colds) that may affect the eye or be exacerbated by use of contact lenses or contact lens solutions;
* Use of systemic medications that may contribute to adverse ocular effects unless on a stable dosing regimen;
* Ocular surgery within the last 12 months;
* Other protocol-defined exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT01912768
Study Brief:
Protocol Section:
NCT01912768