Status:
TERMINATED
An Evaluation of the Efficacy and Safety of AL-46383A Ophthalmic Solution for the Treatment of Adenoviral Conjunctivitis
Lead Sponsor:
Alcon Research
Conditions:
Adenoviral Conjunctivitis
Eligibility:
All Genders
6+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of AL-46383A Ophthalmic Solution for the treatment of adenoviral conjunctivitis.
Eligibility Criteria
Inclusion
- At least one eye must have EITHER a positive adenovirus test (using the Adeno Detector™ 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
- 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.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
452 Patients enrolled
Trial Details
Trial ID
NCT00901693
Start Date
June 1 2009
End Date
July 1 2010
Last Update
May 22 2014
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