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 @ 4:59 AM
Ignite Modification Date:
2025-12-25 @ 4:59 AM
NCT ID:
NCT01839318
Eligibility Criteria:
Inclusion Criteria:
* Sign Informed Consent.
* Adapted soft contact lens wearer.
* Willing to wear contact lenses up to 12 hours and attend all study visits.
* Vision correctable to 0.1 (logMAR) or better in each eye at distance with pre-study lenses at Visit 1.
* Contact lens prescription within the power range specified in the protocol.
* Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
* Any ocular infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear.
* Any use of systemic or ocular medications that would contraindicate contact lens wear.
* Any ocular finding observed during the Visit 1 examination that would contraindicate contact lens wear.
* Monocular (only 1 eye with functional vision) or fit with only 1 lens.
* History of herpetic keratitis, ocular surgery, or irregular cornea.
* Known pregnancy.
* Unstable tear film with a NIK-BUT value below 13 seconds in either eye without lenses.
* Participation in any clinical study within 30 days of Visit 1.
* Other protocol-defined exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
44 Years
Study:
NCT01839318
Study Brief:
Protocol Section:
NCT01839318