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 @ 3:01 PM
Ignite Modification Date:
2025-12-24 @ 3:01 PM
NCT ID:
NCT03539159
Eligibility Criteria:
Inclusion Criteria:
* Subjects with severe signs and symptoms of dry eyes.
* Age 16 years or older.
* Punctate staining of the cornea.
* Expected to benefit from SEDs.
* Not previously treated with SEDs.
Exclusion Criteria:
* Actively or previously treated for Herpes Simplex Virus (HSV) keratitis.
* Corneal lesions, more than punctate.
* Untreated Meibomian gland disease.
* Pregnant or lactating or intending to become pregnant in the next 3 months
* Unable or unwilling to give informed consent.
* Active (systemic) microbial infection.
* The use of all types of contact lenses.
* Discontinuous use of medication that affects the dry eye sensation is not allowed (e.g. discontinuous use of local corticosteroids). Continuous use of co-medication, like lubricants, anti-glaucoma eye drops or other drops, that have to be used on a daily basis are allowed, and are expected to be used throughout the study period in both eyes (continuous use of the same medication is allowed if used at least one month prior to start of the study).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT03539159
Study Brief:
Protocol Section:
NCT03539159