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

Phase 2

Terminated

• Conditions: Adenoviral Conjunctivitis
• Interventions: Drug: AL-46383A Ophthalmic Solution; Drug: AL-46383A Ophthalmic Solution Vehicle

• Registration Number: NCT00901693
• Lead Sponsor: Alcon Research

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study First Submitted: 2009-05-08
• Study First Submitted QC: 2009-05-13
• Study First Posted: 2009-05-14
• Study Start: 2009-06
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Disposition First Submitted: 2014-04-17
• Status Verified: 2014-05
• Disposition First Submitted QC: 2014-05-07
• Last Update Submitted: 2014-05-07
• Disposition First Posted: 2014-05-22
• Last Update Posted: 2014-05-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 452

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AL-46383A	AL-46383A Ophthalmic Solution	AL-46383A Ophthalmic Solution, 1 drop in each eye, 8 times a day for 10 days
Vehicle	AL-46383A Ophthalmic Solution Vehicle	AL-46383A Ophthalmic Solution Vehicle, 1 drop in each eye, 8 times a day, for 10 days

Primary Outcome Measures

Name	Time	Method
Sustained microbiological success at Day 5 or Day 7	Up to Day 18

Secondary Outcome Measures

Name	Time	Method
Time to sustained microbiological success	Up to Day 18