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 @ 11:37 PM
Ignite Modification Date:
2025-12-24 @ 11:37 PM
NCT ID:
NCT04980456
Eligibility Criteria:
Inclusion Criteria:
* Able to understand and sign an approved Informed Consent form;
* Willing and able to attend all scheduled study visits as required by the protocol;
* Currently wearing any commercial spherical weekly/monthly soft contact lenses in both eyes for at least 3 months, minimum 5 days per week, 10 hours per day;
* Manifest cylinder less than or equal to 0.75 diopter (D) in each eye;
* Willing to stop wearing habitual contact lenses for the duration of study participation.
* Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
* Any eye condition that contraindicates contact lens wear, as determined by the Investigator;
* Any use of systemic or ocular medicine that contraindicates contact lens wear, as determined by the Investigator;
* Ocular or intraocular surgery (excluding placement of punctal plugs) within the previous 12 months or planned during the study;
* Any use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear;
* Current or prior Biofinity contact lens wear in the past 3 months prior to consent.
* Other protocol-defined exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04980456
Study Brief:
Protocol Section:
NCT04980456