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 @ 4:19 AM
Ignite Modification Date:
2025-12-25 @ 4:19 AM
NCT ID:
NCT02042820
Eligibility Criteria:
For Dry Eye Disease Participants
Inclusion Criteria:
* Age \>18
* Ability to consent to study
* Symptoms of dry eye disease for at least 6 months, such foreign body sensation, burning, stinging, light sensitivity
* Positive vital dye staining of the cornea
* At least one of the following objective signs: (Schirmer I \<10 mm at 5 minutes), decreased (\<0.2 mm) tear meniscus, decreased tear breakup time (TBUT) of \<10 seconds, positive vital dye staining of the conjunctiva
For Age-Match Controls
Inclusion Criteria:
* Between the ages of 18-89
* The ability to provide informed consent for study inclusion
* Clear, healthy cornea
* Normal tear meniscus (\> 0.3 mm)
For Dry Eye Disease Participants
Exclusion Criteria:
* History of contact lens wear in the past 3 months
* History of ocular surgery in the past 6 months
* Active ocular allergies
* History of ocular infection in the past 3 months
* History of diabetes
* History of topical or systemic anti-inflammatory therapy in the past 1 month
For Age-Match Controls
Exclusion Criteria:
* History of ocular or eyelid surgery within the past 12 months
* History of herpetic or other infectious keratitis or other inflammatory eye disease
* History of any other acute ocular disease
* Current use of topical medications (not including artificial tears)
* Current use of contact lenses
* History of ocular carcinoma or any recent ocular topical chemotherapy or radiotherapy
* History of cancer elsewhere in the body which is currently under systemic chemotherapy
* Current glaucoma disease requiring use of glaucoma drops
* History of Diabetes mellitus
* Current diagnosis of dry eye disease
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02042820
Study Brief:
Protocol Section:
NCT02042820