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Trial record 37 of 76 for:    "Bacterial Infectious Disease" | "Polyestradiol phosphate"

Topical Treatment of Bacterial Conjunctivitis and Its Effect on Microbial Flora

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ClinicalTrials.gov Identifier: NCT00312338
Recruitment Status : Completed
First Posted : April 10, 2006
Results First Posted : February 2, 2010
Last Update Posted : November 2, 2012
Sponsor:
Collaborator:
Tufts University
Information provided by (Responsible Party):
Alcon Research

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Single
Condition Bacterial Conjunctivitis
Intervention Drug: VIGAMOX
Enrollment 137
Recruitment Details Study recruitment started in June 2006 and ran until January 29 2008. The study sites included three sites (AZ, CA and IL)
Pre-assignment Details No specific pre-assignment activities.
Arm/Group Title Infected Patients Healthy Subjects
Hide Arm/Group Description Infected Patients Healthy Subjects
Period Title: Overall Study
Started 105 57
Completed 83 54
Not Completed 22 3
Reason Not Completed
Adverse Event             7             2
Lost to Follow-up             9             1
Withdrawal by Subject             4             0
Subsequent infection             2             0
Arm/Group Title Infected Patients Healthy Subjects Total
Hide Arm/Group Description Infected Patients Healthy Subjects Total of all reporting groups
Overall Number of Baseline Participants 105 57 162
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 105 participants 57 participants 162 participants
<=18 years
105
 100.0%
57
 100.0%
162
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 105 participants 57 participants 162 participants
Female
48
  45.7%
28
  49.1%
76
  46.9%
Male
57
  54.3%
29
  50.9%
86
  53.1%
1.Primary Outcome
Title Susceptability Changes in Streptococcus Pneumoniae Distal to the Site of Instillation
Hide Description

Susceptibility change refers to a change in vulnerability of a specified bacterial strain to antibiotic treatment. Susceptibility was assessed by broth microdilution methods recommended by the Clinical and Laboratory Standards Institute (CLSI).

0% = zero isolates were resistant to antibiotic 100% = all isolates were resistant to antibiotic

Time Frame Day 0 and Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Infected Patients Healthy Subjects
Hide Arm/Group Description:
Infected Patients
Healthy Subjects
Overall Number of Participants Analyzed 83 54
Measure Type: Number
Unit of Measure: Percent of resistant isolates
Day 0 0 0
Day 42 0 0
2.Primary Outcome
Title Susceptability Changes in Staphylococcus Aureus Distal to the Site of Instillation
Hide Description

Susceptibility change refers to a change in vulnerability of a specified bacterial strain to antibiotic treatment. Susceptibility was assessed by broth microdilution methods recommended by the Clinical and Laboratory Standards Institute (CLSI).

0% = zero isolates were resistant to antibiotic 100% = all isolates were resistant to antibiotic

Time Frame Day 0, Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Infected Patients Healthy Subjects
Hide Arm/Group Description:
Infected Patients
Healthy Subjects
Overall Number of Participants Analyzed 83 54
Measure Type: Number
Unit of Measure: Percent of resistant isolates
Day 0 8.3 0
Day 42 0 0
3.Primary Outcome
Title Susceptability Changes in Haemophilus Influenzae Distal to the Site of Instillation
Hide Description

Susceptibility change refers to a change in vulnerability of a specified bacterial strain to antibiotic treatment. Susceptibility was assessed by broth microdilution methods recommended by the Clinical and Laboratory Standards Institute (CLSI).

0% = zero isolates were resistant to antibiotic 100% = all isolates were resistant to antibiotic

Time Frame Day 0, Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Infected Patients Healthy Subjects
Hide Arm/Group Description:
Infected Patients
Healthy Subjects
Overall Number of Participants Analyzed 83 54
Measure Type: Number
Unit of Measure: Percent of resistant isolates
Day 0 0 0
Day 42 0 0
Time Frame Day 0 to Day 42
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Infected Patients Healthy Subjects
Hide Arm/Group Description Infected Patients Healthy Subjects
All-Cause Mortality
Infected Patients Healthy Subjects
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Infected Patients Healthy Subjects
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/105 (0.00%)      0/57 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Infected Patients Healthy Subjects
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/105 (5.71%)      0/57 (0.00%)    
Infections and infestations     
Upper respiratory tract infection  1  6/105 (5.71%)  6 0/57 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
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.
Results Point of Contact
Name/Title: Alcon Clinical
Organization: Alcon Research, Ltd.
Phone: 888.451.3937; 817.568.6725
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00312338     History of Changes
Other Study ID Numbers: CMS-05-11
First Submitted: April 4, 2006
First Posted: April 10, 2006
Results First Submitted: July 15, 2009
Results First Posted: February 2, 2010
Last Update Posted: November 2, 2012