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 @ 4:42 PM
Ignite Modification Date:
2025-12-24 @ 4:42 PM
NCT ID:
NCT02424266
Eligibility Criteria:
Inclusion Criteria:
Age \>/= 18 years Healthy controls - without dry eyes
Patients with a diagnosis of moderate-to-severe KCS as defined by all of the following:
1. The presence of at least one ocular symptom of dryness scored at \> 2 (where 0 = none and 4 = very severe /interferes with normal activities)
2. Positive Schirmer test (ST without anesthesia) \< 7 mm/5 min in either eye
3. Positive fluorescein stainig (FS), defined as a corneal punctate fluorescein staining score of \> 1 in either eye, where 0 = none and 3 = severe.
Exclusion Criteria:
1. Stevens-Johnson Syndrome
2. Post-burn ocular injury
3. Chronic ocular disease other than KCS requiring topical treatment
4. Ocular herpes simplex virus infection
5. Use of contact lenses
6. Persistent Intraocular Inflammation or Infection
7. Active blepharitis of greater than mild degree
8. Recent surgical occlusion of the lacrimal puncta
9. Subepithelial cornea scarring
10. Anesthetic or neurotrophic corneas.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02424266
Study Brief:
Protocol Section:
NCT02424266