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 @ 11:16 PM
Ignite Modification Date:
2025-12-24 @ 11:16 PM
NCT ID:
NCT02688556
Eligibility Criteria:
Inclusion Criteria:
* History of dry eye syndrome (KCS) for a period of at least 6 months
* Clinical diagnosis of bilateral KCS
* Lissamine green conjunctival staining sum score of ≥ 3 to ≤ 9 out of a total possible score of 12 (scoring excludes superior zones 2 and 4) in the same eye at both the Screening and Baseline Visits.
* Global symptom score (SANDE) ≥ 40 mm at both the Screening and Baseline Visits
* Corrected Snellen visual acuity (VA) of better than 20/200 in each eye.
Exclusion Criteria:
* Use of cyclosporine ophthalmic emulsion 0.05% (Restasis®) within 3 months prior to the Screening Visit.
* Previous treatment failure (lack of efficacy) with cyclosporine ophthalmic emulsion 0.05% (Restasis).
* Diagnosis of Sjögren's disease ˃ 5 years prior to the Screening Visit.
* Clinical diagnosis or any history of seasonal and/or perennial allergic conjunctivitis.
* Use of systemic or topical medications within 7 days prior to the Screening Visit or during the study period that are known to cause dry eye.
* Use of any topical ophthalmic medications, prescription (including anti-glaucoma medications) or over the counter (including artificial tears), other than the assigned study medication during the study period.
* Current active eye disease other than dry wyw syndrome (i.e., any disease for which topical or systemic ophthalmic medication is necessary).
* History of herpes keratitis.
* Corneal transplant
* Corneal refractive surgery within 6 months prior to the Screening Visit or postoperative refractive surgery symptoms of dryness that have not resolved.
* Cataract surgery within 3 months prior to the Screening Visit.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02688556
Study Brief:
Protocol Section:
NCT02688556