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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.
Information provided by:
Merck Sharp & Dohme Corp. Identifier:
First received: March 14, 2005
Last updated: November 21, 2013
Last verified: November 2013
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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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:

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of Participants Who Achieved Clinical Resolution at Visit 3 [ Time Frame: Visit 3 (Day 6) ]
    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) ]
    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.


Ages Eligible for Study:   1 Year and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00105469

  Show 26 Study Locations
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp Identifier: NCT00105469     History of Changes
Other Study ID Numbers: P08633
Study First Received: March 14, 2005
Results First Received: August 1, 2011
Last Updated: November 21, 2013

Keywords provided by Merck Sharp & Dohme Corp.:
Bacterial Conjunctivitis
Pink Eye
Eye Infection

Additional relevant MeSH terms:
Conjunctivitis, Bacterial
Conjunctival Diseases
Eye Diseases
Eye Infections, Bacterial
Bacterial Infections
Eye Infections
Ophthalmic Solutions
Pharmaceutical Solutions
Anti-Bacterial Agents
Anti-Infective Agents processed this record on August 18, 2017