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 @ 10:34 PM
Ignite Modification Date:
2025-12-24 @ 10:34 PM
NCT ID:
NCT02694835
Eligibility Criteria:
Inclusion Criteria:
* Must sign an Informed Consent document;
* Current wearers of commercial DT1 lenses (for at least 3 months), with a minimum wearing time of 5 days per week and 8 hours per day;
* Spherical contact lens correction within the range of -2.00 to -4.00 Diopter (D) in both eyes;
* Manifest astigmatism less than or equal to 0.75 D (at screening);
* Best-corrected visual acuity (BCVA) greater than or equal to 20/25 in each eye (as determined by manifest refraction at screening);
* Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
* Eye injury in either eye within 12 weeks prior to study enrollment;
* Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear as determined by the Investigator;
* Use of systemic or ocular medications for which contact lens wear could be contraindicated, including topical ocular medications and lubrication drops that would require instillation during contact lens wear;
* History of herpetic keratitis;
* History of refractive surgery or irregular cornea;
* Pathologically dry eye that precludes contact lens wear;
* Concurrent participation (or within the previous 30 days) in a contact lens or lens care product clinical trial;
* Monocular (only 1 eye with functional vision);
* Other protocol-specified exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02694835
Study Brief:
Protocol Section:
NCT02694835