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 @ 10:58 PM
Ignite Modification Date:
2025-12-24 @ 10:58 PM
NCT ID:
NCT00565669
Eligibility Criteria:
Inclusion Criteria:
1. Subject must have dry eye.
2. Age: 18 years and older.
3. Males or females
4. Up to grade 3 conjunctival staining.
5. Score of no more than 4 on the Subjective Evaluation of Symptoms of Dryness (SESOD) at screening.
6. Currently using Restasis to treat dry eye syndrome (at least for 3 months prior to enrollment).
7. Willing and able to comply with scheduled visits and other study procedures.
Exclusion Criteria:
1. Prior unsuccessful use of topical cyclosporine (defined as patients taking it at least 3 months without improvement.
2. Known contraindications to any study medication or ingredients.
3. Planned use of contact lenses (unless discontinued use more than 30 days prior to randomization.
4. Contact lens use during the active treatment portion of the trial.
5. Active ocular allergies.
6. Ocular surgery within the past 3 months.
7. Any concurrent infectious/non infectious conjunctivitis, keratitis or uveitis.
8. Active ocular diseases or uncontrolled systemic disease (blepharitis patients that are actively being treated or disease that is uncontrollable.
9. Pregnant or nursing mothers and females of childbearing potential not practicing a reliable and medically acceptable method of birth control.
10. Participation in (or current participation) any investigational drug or device trial.
11. Conjuctival staining grade 4.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00565669
Study Brief:
Protocol Section:
NCT00565669