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 @ 10:44 PM
Ignite Modification Date:
2025-12-24 @ 10:44 PM
NCT ID:
NCT00833235
Eligibility Criteria:
Inclusion Criteria:
* Males at least 55 years old or females, at least 40 years old with perimenopausal symptoms
* Baseline OSDI score of ≥ 13
* Patients with mild to moderate dry eye (dry eye disease patients only; not applicable for control group)
Exclusion Criteria:
* Use of any topical cyclosporine ophthalmic emulsion within 3 months of baseline
* History of herpes keratitis or varicella zoster keratitis
* Any history of allergic conjunctivitis
* Temporary or permanent occlusion or cauterization of the lacrimal puncta for either eye
* Any anterior segment surgery involving a limbal or corneal incision (cataract surgery), keratorefractive procedure (LASIK, LASEK, PRK) within 12 months of baseline, or expectation of such surgery within 2 years
* Patients with known systemic disease
* Any history of corneal transplant
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT00833235
Study Brief:
Protocol Section:
NCT00833235