Topical Antibiotics and Intravitreous Injections

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christopher Ta, Stanford University
ClinicalTrials.gov Identifier:
NCT00410891
First received: October 2, 2006
Last updated: May 13, 2014
Last verified: May 2014
Results First Received: May 13, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Single Blind (Investigator)
Conditions: Intravitreous
Injections
Intervention: Drug: gatifloxacin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Topical Antibiotic

topical gatifloxacin 4 times per day

gatifloxacin


Participant Flow:   Overall Study
    Topical Antibiotic  
STARTED     129  
COMPLETED     129  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
patient undergoing IVT

Reporting Groups
  Description
Topical Antibiotic

topical gatifloxacin 4 times per day

gatifloxacin


Baseline Measures
    Topical Antibiotic  
Number of Participants  
[units: participants]
  129  
Age  
[units: years]
Mean ± Standard Deviation
  77  ± 13  
Gender  
[units: participants]
 
Female     81  
Male     48  



  Outcome Measures

1.  Primary:   Positive Culture   [ Time Frame: 2 ]

2.  Primary:   Conjunctival Bacterial Flora   [ Time Frame: 3 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Professor
Organization: Stanford
phone: 6504984791
e-mail: cta@stanford.edu


No publications provided


Responsible Party: Christopher Ta, Stanford University
ClinicalTrials.gov Identifier: NCT00410891     History of Changes
Other Study ID Numbers: 96803 (eProtocol 4384
Study First Received: October 2, 2006
Results First Received: May 13, 2014
Last Updated: May 13, 2014
Health Authority: United States: Institutional Review Board