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Topical Antibiotics and Intravitreous Injections

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00410891
First Posted: December 13, 2006
Last Update Posted: June 12, 2014
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.
Information provided by (Responsible Party):
Christopher Ta, Stanford University
Results First Submitted: May 13, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Single (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 
Overall Participants Analyzed 
[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.  


  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



Responsible Party: Christopher Ta, Stanford University
ClinicalTrials.gov Identifier: NCT00410891     History of Changes
Other Study ID Numbers: 96803 (eProtocol 4384
First Submitted: October 2, 2006
First Posted: December 13, 2006
Results First Submitted: May 13, 2014
Results First Posted: June 12, 2014
Last Update Posted: June 12, 2014