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 @ 3:29 AM
Ignite Modification Date:
2025-12-25 @ 3:29 AM
NCT ID:
NCT03417505
Eligibility Criteria:
Inclusion Criteria:
* Reduced tear film break up time (TBUT), a sign of dry eye disease and contact lens discomfort
* Scleral lens wearer (at least 8 hours per day for at least 5 days per week and have had their habitual lenses no longer than 1 year). Scleral lenses wear will be defined as 15.00 mm to 19.00 mm inclusive.
Exclusion Criteria:
* Disorders that affect sensitivity (herpetic disease, severe diabetes mellitus)
* Anatomic variations of the conjunctiva that can impair proper scleral lens fitting
* Pregnancy
* Best corrected Snellen visual acuity worse than 20/30 in either eye
* Ocular pathology other than dry eye (e.g. glaucoma, macular degeneration, keratoconus) which may significantly impact visual function.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03417505
Study Brief:
Protocol Section:
NCT03417505