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

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ClinicalTrials.gov Identifier: NCT00105534
Recruitment Status : Completed
First Posted : March 16, 2005
Results First Posted : October 27, 2011
Last Update Posted : November 21, 2013
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Bacterial Conjunctivitis
Interventions Drug: AzaSite
Other: Vehicle
Enrollment 685
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AzaSite Vehicle
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: Overall Study
Started 335 350
Completed 313 317
Not Completed 22 33
Reason Not Completed
Adverse Event             2             5
Protocol Violation             1             4
Withdrawal by Subject             6             6
Lost to Follow-up             5             1
Lack of Efficacy             7             15
Treatment unmasked             1             0
Other Reason             0             2
Arm/Group Title AzaSite Vehicle Total
Hide Arm/Group Description Per protocol population defined as all randomized participants who had administered at least one drop of study drug, who had eye cultures indicating pathogenic bacteria levels as well as the clinical signs of conjunctivitis at Visit 1 and had at least one post first dose clinical assessment. Per protocol population defined as all randomized participants who had administered at least one drop of study drug, who had eye cultures indicating pathogenic bacteria levels as well as the clinical signs of conjunctivitis at Visit 1 and had at least one post first dose clinical assessment. Total of all reporting groups
Overall Number of Baseline Participants 130 149 279
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 130 participants 149 participants 279 participants
25.6  (24.49) 30.8  (28.07) 28.4  (26.54)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 130 participants 149 participants 279 participants
Female
82
  63.1%
78
  52.3%
160
  57.3%
Male
48
  36.9%
71
  47.7%
119
  42.7%
1.Primary Outcome
Title Participants Who Achieved Clinical Resolution
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population (defined as all randomized participants who had administered at least one drop of study drug, who had eye cultures indicating pathogenic bacteria levels as well as the clinical signs of conjunctivitis at Visit 1 and had at least one post first dose clinical assessment) with last observation carried forward.
Arm/Group Title AzaSite Vehicle
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 130 149
Measure Type: Number
Unit of Measure: Participants
82 74
2.Secondary Outcome
Title Participants Who Achieved Bacteriological Eradication
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population (defined as all randomized participants who had administered at least one drop of study drug, who had eye cultures indicating pathogenic bacteria levels as well as the clinical signs of conjunctivitis at Visit 1 and had at least one post first dose clinical assessment) with last observation carried forward.
Arm/Group Title AzaSite Vehicle
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 130 149
Measure Type: Number
Unit of Measure: Participants
115 99
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AzaSite Vehicle
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
AzaSite Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
AzaSite Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/333 (0.00%)      2/350 (0.57%)    
Eye disorders     
Cornela Ulcer  0/333 (0.00%)  0 1/350 (0.29%)  1
Nervous system disorders     
Cerebrovascular Accident  0/333 (0.00%)  0 1/350 (0.29%)  1
1
Term from vocabulary, MedDRA (7.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AzaSite Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/333 (0.00%)      0/350 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Institution and Principal Investigator shall not publish, present or use any data or results arising out of the performance of this study for their own instruction, research or publication without the prior express written consent of Sponsor.
Results Point of Contact
Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00105534     History of Changes
Other Study ID Numbers: P08635
C-01-401-003
First Submitted: March 15, 2005
First Posted: March 16, 2005
Results First Submitted: August 1, 2011
Results First Posted: October 27, 2011
Last Update Posted: November 21, 2013