An Evaluation of the Efficacy and Safety of AL-46383A Ophthalmic Solution for the Treatment of Ad… (NCT00901693) | Clinical Trial Compass
TerminatedPhase 2
An Evaluation of the Efficacy and Safety of AL-46383A Ophthalmic Solution for the Treatment of Adenoviral Conjunctivitis
Stopped: Internal business decision
452 participantsStarted 2009-06
Plain-language summary
The purpose of this study is to evaluate the safety and efficacy of AL-46383A Ophthalmic Solution for the treatment of adenoviral conjunctivitis.
Who can participate
Age range6 Years
SexALL
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Inclusion Criteria:
* 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 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 poster…
What they're measuring
1
Sustained microbiological success at Day 5 or Day 7