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 @ 1:17 AM
Ignite Modification Date:
2025-12-25 @ 1:17 AM
NCT ID:
NCT00901693
Eligibility Criteria:
Inclusion Criteria:
* At least one eye must have EITHER a positive adenovirus test (using the Adeno Detectorâ„¢ for Adenoviral Conjunctivitis, Rapid Pathogen Screening, Inc.) OR a positive clinical diagnosis assessed by the Adenoviral Clinical Diagnostic Checklist.
* Onset and development of ocular symptoms and/or signs of conjunctivitis ≤ 7 days prior to enrollment (Day 1) in either eye.
* Able to understand and sign an informed consent form that has been approved by an Institutional Review Board/ Independent Ethics Committee (IRB/IEC).
* Must agree to comply with the visit schedule and other requirements of the study.
* Females who are not pregnant and are not lactating. All females of childbearing potential (those who are not pre-menarcheal, not postmenopausal or surgically sterile) may participate only if they have a negative urine pregnancy test prior to randomization, and if they agree to use adequate birth control methods to prevent pregnancy throughout the study.
* Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
* Sub-epithelial infiltrates at the Day 1 visit in either eye.
* Corneal opacity or any corneal abnormality at the Day 1 visit in either eye.
* Contact lens wear during the course of the study. Participants requiring correction must have spectacles with appropriate correction.
* Only one sighted eye or vision in either eye not correctable to 0.6 or better logMAR (using ETDRS chart) at the Day 1 visit.
* Abnormal findings in the posterior pole of the retina or any media opacity found in a dilated fundus examination at the Day 1 (Screening/ Baseline) visit.
* Suspected fungal, herpes, Chlamydia or Acanthamoeba infection, based on clinical observation.
* History of active uveitis or iritis in either eye.
* History of corneal transplant in either eye.
* Presence of nasolacrimal duct obstruction at Day 1.
* Use of specified prohibited medications.
* Other protocol-defined exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Study:
NCT00901693
Study Brief:
Protocol Section:
NCT00901693