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:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-25 @ 2:27 AM
NCT ID:
NCT00266734
Eligibility Criteria:
Inclusion Criteria:
Clinical Study Enrollment Criteria
Upon completing the in-vitro studies, a perspective, blinded clinical study was started. Patients who were older than 1 month of age, seen within 7 days of developing a red eye, and who demonstrate at least one criterion from two out of the three categories below were included:
I. History: 1) Spread from one eye to the other several days later, 2) recent or concurrent upper respiratory symptoms within the preceding two weeks, 3) or an exposure to someone with "pink eye" within the preceding three weeks
II. Symptoms: 1) Tearing, 2) mucoid or purulent discharge, 3) eye lash matting, 4) burning, 5) itching, or 6) foreign body sensation
III. Signs: 1) An inferior palpebral conjunctival reaction with \> or = 1+ papillary or follicular reactions, 2) presence of a preauricular node
Exclusion Criteria:
Patients with associated skin vesicles, corneal dendrites, traumatic corneal abrasion, concurrent corneal ulcers, foreign bodies, ocular pemphigoid, trauma, previous history of chemical/thermal injury to eyes or eyelids (anytime in past), or greater than trace intraocular inflammation were excluded from the study. Additionally, patients with allergy to corn starch, talcum powder, or dacron were also be excluded. Patients using any topical ophthalmic medication (i.e. antibiotics) were required to wait at least 30 minutes from their last dose prior to device application and wait at least 2 hours after their last dose of any ointment application
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Month
Study:
NCT00266734
Study Brief:
Protocol Section:
NCT00266734