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 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 1:32 AM
NCT ID:
NCT01594294
Eligibility Criteria:
Inclusion Criteria:
* Read and understand the Participant Information Sheet;
* Read, sign, and date an Informed Consent;
* Successfully wearing a frequent replacement hydrogel or silicone hydrogel contact lens brand under a frequent replacement (biweekly or monthly) daily wear modality;
* Classified as symptomatic according to protocol-specified criteria;
* Agree to wear study contact lenses as directed for the duration of the study;
* Best corrected visual acuity (BCVA) of 6/9 or better in each eye;
* Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
* Any known sensitivity or intolerance to any of the contact lenses or contact lens care products to be used;
* Monocular vision (only one eye with functional vision or only one eye fitted with contact lenses);
* History of seasonal allergies, which may have an adverse impact on contact lens wear, or data and information obtained in this study;
* Systemic disease or use of medication which might interfere with contact lens wear or produce dry eye side effects;
* Ocular allergies or ocular disease which might interfere with contact lens wear or data and information obtained in this study;
* Active ocular infection;
* Use of any concomitant topical ocular medications during the study period;
* Significant ocular anomaly;
* Previous ocular surgery;
* History of recent, significant changes in visual acuity;
* Any medical condition that might be prejudicial to the study;
* Pregnant, planning to be become pregnant, or lactating at time of enrollment;
* Any infectious disease (e.g. hepatitis, tuberculosis), immunosuppressive disease (e.g. HIV), or diabetes;
* Participation in an investigational drug or device study within 30 days of entering study;
* Other protocol-defined exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01594294
Study Brief:
Protocol Section:
NCT01594294