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

Primary Purpose

Bacterial Conjunctivitis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
AzaSite
Tobramycin
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacterial Conjunctivitis focused on measuring Bacterial Conjunctivitis, Pink Eye, Conjunctivitis, Eye Infection

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Renaissance Center
  • Children's Eye Physicians
  • Palm Beach Eye Associates
  • The Eye Associates
  • Alan Shuster, MD
  • Pasco Eye Institute
  • Tukoi Institute for Clinical Research
  • Advanced Eye Care
  • Presidential Eye Center
  • Jon Fishburn, MD
  • Medisphere Medical Research Center, LLC
  • Hutchinson Clinic
  • Massachusetts Eye and Ear Infirmary
  • Mason Eye Institute
  • Ophthalmology Associates
  • Research Eye Care Center
  • Ophthalmology Associates
  • Huntington Medical Group
  • Cornerstone Eye Care
  • Eye Health Northwest
  • Irving Weinberger, MD
  • Southern Eye Associates, PA
  • Corona Research Consultants, Inc.
  • Cottonwood Ophthalmology Associates
  • Rockwood Clinic, PS-Eye Center
  • Wenatchee Valley Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

AzaSite

Tobramycin

Arm Description

1.0% azithromycin in DuraSite

0.3% tobramycin

Outcomes

Primary Outcome Measures

Number of Participants Who Achieved Clinical Resolution at Visit 3
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
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).

Full Information

First Posted
March 14, 2005
Last Updated
November 21, 2013
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00105469
Brief Title
Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Tobramycin for Bacterial Conjunctivitis (C-01-401-004)
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
October 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Conjunctivitis
Keywords
Bacterial Conjunctivitis, Pink Eye, Conjunctivitis, Eye Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
743 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AzaSite
Arm Type
Experimental
Arm Description
1.0% azithromycin in DuraSite
Arm Title
Tobramycin
Arm Type
Active Comparator
Arm Description
0.3% tobramycin
Intervention Type
Drug
Intervention Name(s)
AzaSite
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Tobramycin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants Who Achieved Clinical Resolution at Visit 3
Description
Clinical resolution is defined as absence of all three clinical signs (ocular discharge, bulbar conjunctival injection, and palpebral conjunctival injection).
Time Frame
Visit 3 (Day 6)
Secondary Outcome Measure Information:
Title
Number of Participants Who Achieved Bacterial Eradication at Visit 3
Description
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).
Time Frame
Visit 3 (Day 6)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Renaissance Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Children's Eye Physicians
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80122
Country
United States
Facility Name
Palm Beach Eye Associates
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
The Eye Associates
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34209
Country
United States
Facility Name
Alan Shuster, MD
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Pasco Eye Institute
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Tukoi Institute for Clinical Research
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33169
Country
United States
Facility Name
Advanced Eye Care
City
Panama City
State/Province
Florida
ZIP/Postal Code
32405
Country
United States
Facility Name
Presidential Eye Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Jon Fishburn, MD
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706
Country
United States
Facility Name
Medisphere Medical Research Center, LLC
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Hutchinson Clinic
City
Hutchinson
State/Province
Kansas
ZIP/Postal Code
67502
Country
United States
Facility Name
Massachusetts Eye and Ear Infirmary
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Mason Eye Institute
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
Ophthalmology Associates
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Research Eye Care Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
Ophthalmology Associates
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
Facility Name
Huntington Medical Group
City
Huntington Station
State/Province
New York
ZIP/Postal Code
11746
Country
United States
Facility Name
Cornerstone Eye Care
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Eye Health Northwest
City
Portland
State/Province
Oregon
ZIP/Postal Code
97209
Country
United States
Facility Name
Irving Weinberger, MD
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15228
Country
United States
Facility Name
Southern Eye Associates, PA
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Corona Research Consultants, Inc.
City
El Paso
State/Province
Texas
ZIP/Postal Code
79904
Country
United States
Facility Name
Cottonwood Ophthalmology Associates
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Rockwood Clinic, PS-Eye Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99205
Country
United States
Facility Name
Wenatchee Valley Medical Center
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17652708
Citation
Protzko E, Bowman L, Abelson M, Shapiro A; AzaSite Clinical Study Group. Phase 3 safety comparisons for 1.0% azithromycin in polymeric mucoadhesive eye drops versus 0.3% tobramycin eye drops for bacterial conjunctivitis. Invest Ophthalmol Vis Sci. 2007 Aug;48(8):3425-9. doi: 10.1167/iovs.06-1413.
Results Reference
derived
Links:
URL
http://www.insitevision.com
Description
Related Info

Learn more about this trial

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

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