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 @ 9:54 PM
Ignite Modification Date:
2025-12-24 @ 9:54 PM
NCT ID:
NCT01393132
Eligibility Criteria:
Inclusion Criteria:
* Schirmers of \< 5 mm at 5 minutes
* TFBUT: less than 10 seconds
* Corneal staining of \>3 of 15: conjunctival staining of \>3 of 18
* Ocular Surface Disease Index of \> 50
* Presumed best corrected vision of 20/60 or better
Exclusion Criteria:
* Acute or inflammatory corneal disease
* Pregnancy or lactation
* Monocular status
* Punctal occlusion within 30 days
* Ocular surgery within 3 months
* Corneal thinning of \>50%
* Active corneal infection
* History of ocular malignancy
* Retinal neovascularization
* Current use of topical cyclosporin A
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT01393132
Study Brief:
Protocol Section:
NCT01393132