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Trial record 27 of 29 for:    "Conjunctival Disease" | "Azithromycin"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00105469
Recruitment Status : Completed
First Posted : March 15, 2005
Results First Posted : October 27, 2011
Last Update Posted : December 16, 2013
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Bacterial Conjunctivitis
Interventions Drug: AzaSite
Drug: Tobramycin
Enrollment 743
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AzaSite Tobramycin
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: Overall Study
Started 365 378
Completed 343 367
Not Completed 22 11
Reason Not Completed
Adverse Event             9             8
Protocol Violation             4             0
Withdrawal by Subject             2             3
Lost to Follow-up             1             0
Lack of Efficacy             2             0
Other Reason             4             0
Arm/Group Title AzaSite Tobramycin Total
Hide Arm/Group Description

Per protocol population (defined as all randomized

subjects who had administered at least one drop of the appropriate study drug, demonstrated evidence of

pathogenic bacteria levels, presented clinical signs of conjunctivitis at Visit 1, and returned for at least one post-first dose clinical assessment) with last observation carried forward.

Per protocol population (defined as all randomized

subjects who had administered at least one drop of the appropriate study drug, demonstrated evidence of

pathogenic bacteria levels, presented clinical signs of conjunctivitis at Visit 1, and returned for at least one post-first dose clinical assessment) with last observation carried forward.

Total of all reporting groups
Overall Number of Baseline Participants 159 157 316
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 159 participants 157 participants 316 participants
17.9  (20.23) 22.8  (22.61) 20.4  (21.55)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 159 participants 157 participants 316 participants
Female
81
  50.9%
90
  57.3%
171
  54.1%
Male
78
  49.1%
67
  42.7%
145
  45.9%
1.Primary Outcome
Title Number of Participants Who Achieved Clinical Resolution at Visit 3
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 (Day 6)
Hide Outcome Measure Data
Hide Analysis Population Description

Per protocol population (defined as all randomized

subjects who had administered at least one drop of the appropriate study drug, demonstrated evidence of

pathogenic bacteria levels, presented clinical signs of conjunctivitis at Visit 1, and returned for at least one post-first dose clinical assessment) with last observation carried forward.

Arm/Group Title AzaSite Tobramycin
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 159 157
Measure Type: Number
Unit of Measure: Participants
127 123
2.Secondary Outcome
Title Number of Participants Who Achieved Bacterial Eradication at Visit 3
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description

Per protocol population (defined as all randomized

subjects who had administered at least one drop of the appropriate study drug, demonstrated evidence of

pathogenic bacteria levels, presented clinical signs of conjunctivitis at Visit 1, and returned for at least one post-first dose clinical assessment) with last observation carried forward.

Arm/Group Title AzaSite Tobramycin
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 159 157
Measure Type: Number
Unit of Measure: Participants
140 148
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AzaSite Tobramycin
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
AzaSite Tobramycin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
AzaSite Tobramycin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/365 (0.00%)   0/378 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AzaSite Tobramycin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/365 (0.00%)   0/378 (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: Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00105469     History of Changes
Other Study ID Numbers: P08633
C-01-401-004
First Submitted: March 14, 2005
First Posted: March 15, 2005
Results First Submitted: August 1, 2011
Results First Posted: October 27, 2011
Last Update Posted: December 16, 2013