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 @ 12:15 PM
Ignite Modification Date:
2025-12-24 @ 12:15 PM
NCT ID:
NCT00399061
Eligibility Criteria:
Inclusion Criteria:
* · Males or females \> 18 years old
* Score of at least 2 and no more than 4 on the SESOD at the initial screening visit (mild to severe patients)
* At least Grade 2 conjunctival staining
* Likely to complete all study visits and able to provide informed consent
Exclusion Criteria:
* · Prior unsuccessful use of topical cyclosporine (defined as patients taking it at least 3 months and saw no improvements)
* Current use of topical cyclosporine
* Known contraindications to any study medication or ingredients
* Female of child bearing potential not using reliable methods of birth control, or pregnant or lactating females.
* Planned use of contact lenses (unless discontinued use ³ 30 days prior to randomization)
* Active ocular diseases or uncontrolled systemic disease (blepharitis patients that are actively being treated or disease that is uncontrollable)
* Ocular surgery within the past 3 months,
* Active ocular allergies
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00399061
Study Brief:
Protocol Section:
NCT00399061