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	Treatment or Intervention	Phase
Bacterial Conjunctivitis	Drug: AzaSite	Phase III

Further Study Details: 

Primary Outcomes: Clinical assesments of ocular discharge; Bacteriological Cultures
Secondary Outcomes: Adverse events; Visual acuity; Biomicroscopy; Ophthalmoscopy
Expected Total Enrollment:  800

Ages Eligible for Study:  1 Year and above,  Genders Eligible for Study:  Both

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.

Alabama
      Renaissance Center, Birmingham,  Alabama,  35205,  United States; Recruiting
Arizona
      Cornea Consultants of Arizona, Phoenix,  Arizona,  85032,  United States; Recruiting
      Risser Thomas Eye Clinic, Phoenix,  Arizona,  85020,  United States; Recruiting
California
      Sutter North Medical Group, Yuba City,  California,  95991,  United States; Recruiting
      West Coast Eye Care, San Diego,  California,  92115,  United States; Recruiting
      East West Eye Institute, Los Angeles,  California,  90013,  United States; Recruiting
      Macy Eye Center, Los Angeles,  California,  90048,  United States; Recruiting
Colorado
      Children's Eye Physicians, Littleton,  Colorado,  80122,  United States; Recruiting
Connecticut
      Danbury Eye Physicians & Surgeons, PC, Danbury,  Connecticut,  06810,  United States; Recruiting
Florida
      Advanced Eye Care, Panama City,  Florida,  32405,  United States; Recruiting
      The Eye Associates, Bradenton,  Florida,  34209,  United States; Recruiting
      Pasco Eye Institute, New Port Richey,  Florida,  34652,  United States; Recruiting
      Tukoi Institute for Clinical Research, North Miami Beach,  Florida,  33169,  United States; Recruiting
      Palm Beach Eye Associates, Atlantis,  Florida,  33462,  United States; Recruiting
      Alan Shuster, MD, Jupiter,  Florida,  33458,  United States; Recruiting
      Presidential Eye Center, West Palm Beach,  Florida,  33401,  United States; Recruiting
      Florida Ophthalmic Institute, Gainesville,  Florida,  32605,  United States; Recruiting
Idaho
      Jon Fishburn, MD, Boise,  Idaho,  83706,  United States; Recruiting
Indiana
      Medisphere Medical Research Center, LLC, Evansville,  Indiana,  47714,  United States; Recruiting
Kansas
      Hutchinson Clinic, Hutchinson,  Kansas,  67502,  United States; Recruiting
Louisiana
      Tulane University Hospital and Clinic, New Orleans,  Louisiana,  70112,  United States; Recruiting
      LSU Health Sciences Center, LSU Eye Center, New Orleans,  Louisiana,  70112,  United States; Recruiting
Maryland
      Wilmer Ophthalmological Institute Johns Hopkins at Green Spring, Lutherville,  Maryland,  21093,  United States; Recruiting
      Seidenberg Protzko Eye Associates, Bel Air,  Maryland,  21014,  United States; Recruiting
Massachusetts
      Massachusetts Eye and Ear Infirmary, Boston,  Massachusetts,  02114,  United States; Recruiting
      Cornea Consultants, Boston,  Massachusetts,  02114,  United States; Recruiting
Missouri
      Research Eye Care Center, Kansas City,  Missouri,  64132,  United States; Recruiting
      Ophthalmology Associates, Creve Coeur,  Missouri,  63141,  United States; Recruiting
      Mason Eye Institute, Columbia,  Missouri,  65212,  United States; Recruiting
Nevada
      Nevada Eye Care Professionals, Las Vegas,  Nevada,  89119,  United States; Recruiting
New Jersey
      Ophthalmology Associates, Princeton,  New Jersey,  08540,  United States; Recruiting
New Mexico
      Eye Associates - New Mexico, Albuquerque,  New Mexico,  87102,  United States; Recruiting
New York
      Huntington Medical Group, Huntington Station,  New York,  11746,  United States; Recruiting
      University of Rochester, Rochester,  New York,  14642,  United States; Recruiting
North Carolina
      Cornerstone Eye Care, High Point,  North Carolina,  27262,  United States; Recruiting
      Asheville Eye Associates, Asheville,  North Carolina,  28803,  United States; Recruiting
Oregon
      Eye Health Northwest, Portland,  Oregon,  97209,  United States; Recruiting
Pennsylvania
      Irving Weinberger, MD, Pittsburgh,  Pennsylvania,  15228,  United States; Recruiting
South Carolina
      Southern Eye Associates, PA, Greenville,  South Carolina,  29605,  United States; Recruiting
      Jervey Eye Group, P.A., Greenville,  South Carolina,  29607,  United States; Recruiting
Texas
      Corona Research Consultants, Inc., El Paso,  Texas,  79904,  United States; Recruiting
      Surgical Eye Associates, P.A., Houston,  Texas,  77008,  United States; Recruiting
      Hermann Eye Center, Houston,  Texas,  77030,  United States; Recruiting
Utah
      Cottonwood Ophthalmology Associates, Murray,  Utah,  84107,  United States; Recruiting
Washington
      Wenatchee Valley Medical Center, Wenatchee,  Washington,  98801,  United States; Recruiting
      Rockwood Clinic, PS-Eye Center, Spokane,  Washington,  99205,  United States; Recruiting

Study ID Numbers:  C-01-401-004
Record last reviewed:  March 2005
Last Updated:  March 23, 2005
Record first received:  March 14, 2005
ClinicalTrials.gov Identifier:  NCT00105469
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08