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 @ 3:49 PM
Ignite Modification Date:
2025-12-24 @ 3:49 PM
NCT ID:
NCT01733992
Eligibility Criteria:
Inclusion Criteria:
* Mild to moderate Keratoconjunctivitis Sicca.
* A corrected visual acuity in both eyes of 20/40 or better.
* An intraocular pressure of \< 21 mm Hg with a difference between eyes of \< 6 mm Hg.
Exclusion Criteria:
* History or evidence of ocular infection, inflammation, or conjunctivitis within 2 months prior to the first dosing day.
* History or evidence of blepharitis requiring the use of antibiotics or eye scrubs within 2 months prior to the first dosing day.
* History of herpes simplex keratitis at any time.
* Current ocular allergy symptoms.
* Recent use of eye medications such as steroids or cyclosporine
* Refractive eye surgery within 12 months of the first dosing day.
* Other eye surgeries within 4 months of the first dosing day.
* Current use of contact lenses or discontinuation of contact lens use within 2 weeks of the first dosing day.
* Receipt of any blood or blood products within 90 days prior to the first dosing day.
* Participation in any clinical study within 30 days prior to the first dosing day.
* History of disease, or currently have a significant illness or abnormal laboratory finding as determined by your study doctor.
* Positive for hepatitis B, hepatitis C or HIV.
* Smoked regularly within 12 months of first dosing day.
* History of substance abuse, drug addiction or alcoholism.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01733992
Study Brief:
Protocol Section:
NCT01733992