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

Primary Purpose

Bacterial Conjunctivitis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
AzaSite
Vehicle
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, Eye Discharge

Eligibility Criteria

12 Months - 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, 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

Sites / Locations

  • I Care! Eye Care!
  • Rx For Life, Inc.
  • North Bay Eye Associates
  • San Diego Eye and Laser Center
  • Western States Clinical Research
  • Opticare Eye Health Center
  • International Eye Center
  • Welborn Clinic and Welborn Clinic East
  • Taustine Eye Center
  • Bossier Optical Inc.
  • Bohn and Joseph Eye Center
  • The Louisiana Eye Center
  • Mississippi Eye Associates
  • Clinical Research Laboratories
  • Advanced Eyecare and Laser Center
  • Precision Eye Care
  • Charlotte Eye, Ear, Nose, and Throat
  • Horizon Eye Center
  • Groat Eyecare Associates
  • Abrams Eye Center
  • Bend Memorial Clinic
  • University Eye Surgeons
  • Total Eye Care, PA
  • Eye Associates
  • Metaclin Research, Inc.
  • Physicians Eye Associates & Cosmetic Laser
  • Marc Sanders, MD
  • Mark Mayo, MD
  • Sun Research Institute
  • Mountain View Eye Center
  • Cottonwood Eye and Laser Clinic
  • Advanced Healthcare, SC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

AzaSite

Vehicle

Arm Description

Outcomes

Primary Outcome Measures

Participants Who Achieved Clinical Resolution
Clinical Resolution is defined as absence of all three clinical signs: ocular discharge, bulbar conjunctival injection, and palpebral conjunctival injection.

Secondary Outcome Measures

Participants Who Achieved Bacteriological Eradication
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).

Full Information

First Posted
March 15, 2005
Last Updated
October 29, 2013
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00105534
Brief Title
Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Vehicle for Bacterial Conjunctivitis (C-01-401-003)
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 Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
January 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
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 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.

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, Eye Discharge

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
685 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AzaSite
Arm Type
Experimental
Arm Title
Vehicle
Arm Type
Sham Comparator
Intervention Type
Drug
Intervention Name(s)
AzaSite
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Vehicle
Intervention Description
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.
Primary Outcome Measure Information:
Title
Participants Who Achieved Clinical Resolution
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 (Days 6-7)
Secondary Outcome Measure Information:
Title
Participants Who Achieved Bacteriological Eradication
Description
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).
Time Frame
Visit 3 (Day 6-7)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
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, 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
Facility Information:
Facility Name
I Care! Eye Care!
City
Flagstaff
State/Province
Arizona
ZIP/Postal Code
86001
Country
United States
Facility Name
Rx For Life, Inc.
City
Cudahy
State/Province
California
ZIP/Postal Code
90201
Country
United States
Facility Name
North Bay Eye Associates
City
Petaluma and Santa Rosa
State/Province
California
ZIP/Postal Code
95401
Country
United States
Facility Name
San Diego Eye and Laser Center
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Western States Clinical Research
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Opticare Eye Health Center
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
International Eye Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Welborn Clinic and Welborn Clinic East
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47713
Country
United States
Facility Name
Taustine Eye Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
Bossier Optical Inc.
City
Bossier City
State/Province
Louisiana
ZIP/Postal Code
71111
Country
United States
Facility Name
Bohn and Joseph Eye Center
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70506
Country
United States
Facility Name
The Louisiana Eye Center
City
Zachary
State/Province
Louisiana
ZIP/Postal Code
70791
Country
United States
Facility Name
Mississippi Eye Associates
City
Ocean Springs
State/Province
Mississippi
ZIP/Postal Code
39564
Country
United States
Facility Name
Clinical Research Laboratories
City
Piscataway
State/Province
New Jersey
ZIP/Postal Code
08854
Country
United States
Facility Name
Advanced Eyecare and Laser Center
City
Runnemede
State/Province
New Jersey
ZIP/Postal Code
08078
Country
United States
Facility Name
Precision Eye Care
City
Huntington
State/Province
New York
ZIP/Postal Code
11743
Country
United States
Facility Name
Charlotte Eye, Ear, Nose, and Throat
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Horizon Eye Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
Groat Eyecare Associates
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
Abrams Eye Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44115
Country
United States
Facility Name
Bend Memorial Clinic
City
Bend
State/Province
Oregon
ZIP/Postal Code
97701
Country
United States
Facility Name
University Eye Surgeons
City
Maryville
State/Province
Tennessee
ZIP/Postal Code
37803
Country
United States
Facility Name
Total Eye Care, PA
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Eye Associates
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Metaclin Research, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78704
Country
United States
Facility Name
Physicians Eye Associates & Cosmetic Laser
City
Houston
State/Province
Texas
ZIP/Postal Code
77002
Country
United States
Facility Name
Marc Sanders, MD
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Mark Mayo, MD
City
Pasadena
State/Province
Texas
ZIP/Postal Code
77504
Country
United States
Facility Name
Sun Research Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78205
Country
United States
Facility Name
Mountain View Eye Center
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
Cottonwood Eye and Laser Clinic
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Advanced Healthcare, SC
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18374301
Citation
Abelson MB, Heller W, Shapiro AM, Si E, Hsu P, Bowman LM; AzaSite Clinical Study Group. Clinical cure of bacterial conjunctivitis with azithromycin 1%: vehicle-controlled, double-masked clinical trial. Am J Ophthalmol. 2008 Jun;145(6):959-65. doi: 10.1016/j.ajo.2008.01.019. Epub 2008 Mar 28.
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 Vehicle for Bacterial Conjunctivitis (C-01-401-003)

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