An Evaluation of the Efficacy and Safety of AL-46383A Ophthalmic Solution for the Treatment of Adenoviral Conjunctivitis - nil

Alcon Research Ltd0 个研究点目标入组 1,400 人开始时间: 待定最近更新: 2021年11月24日

研究概览

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•1.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.
•2.Onset and development of ocular symptoms and/or signs of conjunctivitis ≤ 7 days prior to enrollment (Day 1) in either eye.
•3.Be 6 years or older and of any race and either sex.
•4.Must be able to understand and sign an informed consent form that has been approved by an Institutional Review Board/ Independent Ethics Committee (IRB/IEC).
•5.Must agree to comply with the visit schedule and other requirements of the study.
•6.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.

•1.Presence of sub-epithelial infiltrates at the Day 1 visit in either eye.
•2.Presence of corneal opacity or any corneal abnormality at the Day 1 visit in either eye.
•3.Contact lens wear during the course of the study. Participants requiring correction must have spectacles with appropriate correction.
•4.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.
•5.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.
•6.Suspected fungal, herpes, Chlamydia or Acanthamoeba infection, based on clinical observation.
•7.Patients with a history of active uveitis or iritis in either eye.
•8.Patients with a history of corneal transplant in either eye.
•9.Presence of nasolacrimal duct obstruction at Day 1.
•10.Use of specified prohibited medications.

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