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 @ 11:57 PM
Ignite Modification Date:
2025-12-24 @ 11:57 PM
NCT ID:
NCT01313351
Eligibility Criteria:
INCLUSION CRITERIA
Patients older than 18 years of age, who meet the following criteria related to the clinical history and signs will be enrolled:
Group 1: Clinical Dry Eyes
Clinical History Criteria
An Ocular Surface Disease Index (OSDI) of greater than or equal to 13 - \[Appendix #2\]
Clinical Signs Criteria - All of the following must be present
1. Schirmer's Tear Test (with anesthesia) \< 10 mm over 5 minutes
2. Tear Film Break Up Time (TBUT) \< 10 seconds
3. Total Corneal Staining ≥ 1 \[Appendix #1\]
* At least 1/2 of all patients enrolled will have a Schirmer's Tear Test \< 5 mm or demonstrate corneal staining ≥ 2 \[Appendix #1\]
Group 2: Clinical Normal Non-Dry Eyes
Clinical History Criteria
An Ocular Surface Disease Index (OSDI) of \< 7 - \[Appendix #2\]
Clinical Signs Criteria - All 3 of the following must be present
1. Schirmer's Tear Test (with anesthesia) ≥ 10 mm over 5 minutes
2. Tear Film Break Up Time (TBUT) ≥ 10 seconds
3. Total Corneal Staining = 0 \[Appendix #1\]
EXCLUSION CRITERIA
* Patients with allergy to corn starch, talcum powder, or dacron
* Patients with prior eye injury, trauma, or ocular surgery within the previous 3 months
* Patients with non-dry eye ocular inflammation, uveitis, history of herpetic keratitis or zoster keratitis
* Patients with history of a recent ocular infection within the prior 1 month
* Use of oral doxycycline or topical macrolides (AzaSite) within 1 month
* Patients currently receiving, or received in the last 2 weeks of the study , certain medications including topical or systemic corticosteroids, topical or systemic Nonsteroidal (NSAIDs) therapy, topical cyclosporine, or other immunosuppressive therapy
* Patients who are pregnant or lactating
* Before initialization of the study, patients must not have used any topical medications, including artificial tears during the previous 2 hours
* The use of Rigid-Gas permeable contact lenses or the use of soft-contact lenses within 1 month of the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01313351
Study Brief:
Protocol Section:
NCT01313351