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 @ 12:53 AM
Ignite Modification Date:
2025-12-25 @ 12:53 AM
NCT ID:
NCT03586167
Eligibility Criteria:
Inclusion Criteria:
* Able to understand and sign an informed consent form approved by an Institutional review board (IRB);
* Successful wear of spherical monthly replacement soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
* Best-corrected visual acuity (BCVA) 20/25 or better in each eye;
* Willing to stop wearing habitual contact lenses for the duration of study participation.
Exclusion Criteria:
* Any conditions or use of medications that could contraindicate contact lens wear;
* History of or plan to have refractive surgery in either eye;
* Irregular cornea in either eye;
* Ocular or intraocular surgery (excluding placement of punctal plugs) within the previous 12 months or planned during the study;
* Current or history of intolerance, hypersensitivity or allergy to any component of the study products;
* Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
* Use of topical ocular medications and artificial tear or rewetting drops requiring instillation during contact lens wear;
* Habitual Biofinity contact lens wearers.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03586167
Study Brief:
Protocol Section:
NCT03586167