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Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Tobramycin for Bacterial Conjunctivitis (C-01-401-004)

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00105469
First received: March 14, 2005
Last updated: September 20, 2011
Last verified: September 2011
History of Changes
  Purpose

The purpose of this study is to evaluate the clinical and microbial efficacy and safety of AzaSite compared to tobramycin for bacterial conjunctivitis. Adults and children one year of age and older with bacterial conjunctivitis in at least one eye are eligible. Subjects will be randomly assigned to the AzaSite group or Tobramycin group. Three visits will be required for the study.


Condition Intervention Phase
Bacterial Conjunctivitis
 Drug: AzaSite
Drug: Tobramycin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study to Evaluate the Clinical and Microbial Efficacy and Safety of 1.0% AzaSite Compared to 0.3% Tobramycin Ophthalmic Solution in the Treatment of Bacterial Conjunctivitis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Number of Participants Who Achieved Clinical Resolution at Visit 3 [ Time Frame: Visit 3 (Day 6) ] [ Designated as safety issue: No ]
    Clinical resolution is defined as absence of all three clinical signs (ocular discharge, bulbar conjunctival injection, and palpebral conjunctival injection).


Secondary Outcome Measures:
  • Number of Participants Who Achieved Bacterial Eradication at Visit 3 [ Time Frame: Visit 3 (Day 6) ] [ Designated as safety issue: No ]
    Bacterial eradication is defined as eradication of the causative pathogens as indicated by the absence of growth (0 colony forming units/mL) of the original infecting organism(s).


Enrollment: 743
Study Start Date: July 2004
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AzaSite
1.0% azithromycin in DuraSite
 Drug: AzaSite
AzaSite ophthalmic solution; one topical drop to the infected eye or eyes twice daily (in the morning and at bedtime) on Days 1 and 2 followed by once daily (in the morning between 7 and 10am) on Days 3 through 5.
Active Comparator: Tobramycin
0.3% tobramycin
 Drug: Tobramycin
Tobramycin ophthalmic solution; one topical drop to the infected eye or eyes four times daily at 4 to 6 hour intervals (first dose in the morning between 7 and 10am) for 5 days.

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
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 disease or 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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00105469

  Show 26 Study Locations
Sponsors and Collaborators
Merck
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00105469     History of Changes
Other Study ID Numbers: C-01-401-004, P08633
Study First Received: March 14, 2005
Results First Received: August 1, 2011
Last Updated: September 20, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck:
Bacterial Conjunctivitis
Pink Eye
Conjunctivitis
Eye Infection

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Bacterial
Conjunctival Diseases
Eye Diseases
Eye Infections, Bacterial
Bacterial Infections
Eye Infections
 Infection
Tobramycin
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013