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 @ 7:09 PM
Ignite Modification Date:
2025-12-24 @ 7:09 PM
NCT ID:
NCT03026257
Eligibility Criteria:
Inclusion Criteria:
* Must sign informed consent document;
* Vision correctable to 0.1 (LogMAR) or better in each eye at distance with habitual lenses;
* Manifest cylinder (at screening) less than or equal to 0.75 diopter (D) in each eye and spectacle add \<+0.50 D in each eye;
* Current full-time wearer of spherical samfilcon A, comfilcon A, senofilcon C monthly or senofilcon A 2-week replacement lens within the power range of lens powers available;
* Current user of an MPS (excluding OFPM) to care for lenses;
* Willing to answer text messages on a daily basis during the study;
* Willing to discontinue artificial tears during the study and rewetting drops on the days of study visits;
* Use of digital devices (eg, smart phone, tablet, laptop or desktop computer) for 20 consecutive minutes at least twice a week and willing to continue for the duration of the study;
* Other protocol specific inclusion criteria may apply.
Exclusion Criteria:
* Habitual lens wear in an extended wear modality (routinely sleeping in lenses overnight for 1 or more nights per week);
* Any anterior segment infection, inflammation, disease or abnormality that contraindicates contact lens wear;
* History of herpetic keratitis, corneal surgery or irregular cornea;
* Prior refractive surgery;
* Any use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator;
* Currently using or have not discontinued Restasis®, Xiidra™ and/or topical steroids within the past 7 days;
* Use of mechanical eyelid therapy or eyelid scrubs within 14 days before Visit 1 and not willing to discontinue during the study;
* Monocular (only 1 eye with functional vision) or fit with only 1 lens;
* Known pregnancy or lactating;
* Other protocol specific exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03026257
Study Brief:
Protocol Section:
NCT03026257