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 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 12:24 AM
NCT ID:
NCT07288658
Eligibility Criteria:
Inclusion Criteria:
* Are at least 18 years of age and has full legal capacity to volunteer;
* Have signed an information consent letter;
* Are willing and able to follow instructions and maintain the appointment schedule;
* Are existing wearers of WAVE ScleraLens in one or both eyes.
Exclusion Criteria:
* Are participating in any concurrent clinical or research study;
* Have any known active\* ocular disease and/or infection;
* Have known sensitivity to the diagnostic pharmaceuticals to be used in the study;
* Have taken part in another (pharmaceutical) research study within the last 30 days; \* For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and mild dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07288658
Study Brief:
Protocol Section:
NCT07288658