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 @ 2:48 AM
Ignite Modification Date:
2025-12-25 @ 2:48 AM
NCT ID:
NCT02252133
Eligibility Criteria:
Inclusion Criteria:
* Sign Informed Consent document.
* Habitually wear soft contact lenses on a daily disposable or weekly/monthly replacement basis.
* Symptoms of contact lens discomfort as defined by protocol.
* Require contact lenses within the power range of -0.50 diopter (D) to -10.00 D.
* Cylinder, if present, less or equal to 0.75D in either eyes at Visit 1.
* Vision correctable to 20/25 or 0.1 (logMAR) or better in each eye at distance with pre-study lenses at Visit 1.
* Acceptable contact lens fit with both study contact lenses.
* Willing to wear lenses every day for at least for a minimum of five days per week six hours per day, every day if possible and attend all study visits.
* Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
* Currently wearing DT1 or 1DAVTE.
* Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear.
* Use of systemic or ocular medications which contact lens wear could be contraindicated as determined by the investigator.
* Eye injury or surgery within twelve weeks immediately prior to enrollment for this trial.
* Any moderate or severe ocular condition observed during the slit-lamp examination at the enrollment visit.
* History of herpetic keratitis, ocular surgery or irregular cornea.
* Prior refractive surgery (e.g. LASIK, PRK, etc).
* Monocular subjects (only one eye with functional vision) or subjects fit with only one lens.
* Judged ineligible as a patient in this clinical study by the investigator.
* Other protocol-defined exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT02252133
Study Brief:
Protocol Section:
NCT02252133