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Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Vehicle for Bacterial Conjunctivitis (C-01-401-003)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00105534
Recruitment Status : Completed
First Posted : March 16, 2005
Results First Posted : October 27, 2011
Last Update Posted : November 21, 2013
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Study Description
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Brief Summary:
The purpose of this study is to evaluate the clinical and microbial efficacy and safety of AzaSite compared to vehicle for bacterial conjunctivitis. Adults and children one year of age and older with bacterial conjunctivitis in at least one eye may be eligible. Subjects will be randomly assigned to receive either 1.0 % AzaSite or Vehicle. Three visits will be required for this study.

Condition or disease Intervention/treatment Phase
Bacterial Conjunctivitis Drug: AzaSite Other: Vehicle Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 685 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Study to Evaluate the Clinical and Microbial Efficacy and Safety of 1.0 % AzaSite Compared to Vehicle in the Treatment of Bacterial Conjunctivitis
Study Start Date : July 2004
Actual Primary Completion Date : January 2006
Actual Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pink Eye

Arms and Interventions
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Arm Intervention/treatment
Experimental: AzaSite Drug: AzaSite

1.0% AzaSite contains 1.0% azithromycin, sodium hydroxide, mannitol, poloxamer 407, citric acid anhydrous, sodium citrate, DuraSite® (polycarbophil, sodium chloride, EDTA disodium and water for injection) and benzalkonium chloride 0.003%. AzaSite was prescribed as a single topical drop to the infected

eye(s) for 5 days, twice on the first two days (once in the morning and at bedtime) and once a day in the morning (between 7-10 AM) for the following three days.
Sham Comparator: Vehicle Other: Vehicle
Vehicle contains sodium hydroxide, mannitol, poloxamer 407, citric acid anhydrous, sodium citrate, DuraSite® (polycarbophil, sodium chloride, EDTA disodium and water for injection) and benzalkonium chloride 0.003%. Vehicle was prescribed as a single topical drop to the infected eye(s) for 5 days, twice on the first two days (once in the morning and at bedtime) and once a day in the morning (between 7-10 AM) for the following three days.


Outcome Measures
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Primary Outcome Measures :
  1. Participants Who Achieved Clinical Resolution [ Time Frame: Visit 3 (Days 6-7) ]
    Clinical Resolution is defined as absence of all three clinical signs: ocular discharge, bulbar conjunctival injection, and palpebral conjunctival injection.


Secondary Outcome Measures :
  1. Participants Who Achieved Bacteriological Eradication [ Time Frame: Visit 3 (Day 6-7) ]
    Bacterial eradication is defined as the eradication of the causative pathogens as indicated by the absence of growth (0 colony forming units/mL) of the original infecting organism(s).


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subject, of any race, who is at least 1 year of age.
  • Subjects must have a clinical diagnosis of acute bacterial conjunctivitis and exhibit mucopurulent or purulent conjunctival discharge (crusty or sticky eyelids, globular and yellow discharge) and redness in at least one eye.
  • The symptoms of bacterial conjunctivitis must be present for 3 days (approximately 72 hours) or less.
  • Must be willing to discontinue contact lens wear for the duration of the study.

Exclusion Criteria:

  • Any uncontrolled, systemic, debilitating disease.
  • Use of topical ophthalmic solutions including tear substitutes within 2 hours before and during the study.
  • Use of any topical ophthalmic anti-inflammatory agents within 48 hours before and during the study.
  • Any active upper respiratory tract infection.
  • Pregnant or nursing females.
  • Use of any antibiotic (topical or systemic) within 72 hours of enrollment
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00105534


Locations
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Sponsors and Collaborators
Merck Sharp & Dohme LLC
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT00105534    
Other Study ID Numbers: P08635
C-01-401-003
First Posted: March 16, 2005    Key Record Dates
Results First Posted: October 27, 2011
Last Update Posted: November 21, 2013
Last Verified: October 2013
Keywords provided by Merck Sharp & Dohme LLC:
Bacterial Conjunctivitis
Pink Eye
Conjunctivitis
Eye Infection
Eye Discharge
Additional relevant MeSH terms:
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Conjunctivitis, Bacterial
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Eye Infections, Bacterial
Bacterial Infections
 Bacterial Infections and Mycoses
Infections
Eye Infections
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents