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 @ 5:09 PM
Ignite Modification Date:
2025-12-24 @ 5:09 PM
NCT ID:
NCT01699750
Eligibility Criteria:
Inclusion Criteria:
* Read and understand the Participant Information Sheet;
* Read, sign, and date the Informed Consent;
* Be a current silicone hydrogel contact lens wearer using the contact lenses under a frequent replacement (bi-weekly or monthly) daily wear modality;
* Be classified as symptomatic and a depositor at the end of the replacement period according to protocol-specified criteria;
* Agree to wear study contact lenses as directed for the duration of the study and maintain the appointment schedule;
* Best corrected visual acuity of 6/9 or better in each eye;
* Normal eyes with the exception of the need for visual correction;
* Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
* 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);
* Use of systemic medication which might interfere with contact lens wear or produce dry eye side effects;
* Systemic disease which might interfere with contact lens wear or produce dry eye side effects;
* Systemic or ocular allergies which might interfere with contact lens wear;
* Ocular disease which might interfere with contact lens wear;
* Active ocular infection;
* Use of any concomitant topical ocular medications during the study period;
* Previous ocular surgery;
* Pregnant, planning to become pregnant, or lactating at the time of enrollment;
* Participation in an investigational drug or device study within 30 days of entering this study;
* Other protocol-defined exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01699750
Study Brief:
Protocol Section:
NCT01699750