Topical Antibiotics and Intravitreous Injections

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. Identifier: NCT00410891
Recruitment Status : Completed
First Posted : December 13, 2006
Results First Posted : June 12, 2014
Last Update Posted : November 6, 2017
Information provided by (Responsible Party):
Christopher Ta, Stanford University

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Conditions: Intravitreous
Intervention: Drug: gatifloxacin

  Participant Flow

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
Topical Antibiotic

topical gatifloxacin 4 times per day


Participant Flow:   Overall Study
    Topical Antibiotic
STARTED   129 

  Baseline Characteristics

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
Topical Antibiotic

topical gatifloxacin 4 times per day


Baseline Measures
   Topical Antibiotic 
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Mean (Standard Deviation)
 77  (13) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      81  62.8% 
Male      48  37.2% 
Conjunctival Bacterial Flora [1] 
[Units: Percentage of patients]
Coagulase-negative staphylococcus   75 
Staphylococcus aureus   7 
Gram-negative rods   6 
Streptococcus species   7 
[1] Percentage of patients with bacterial isolates of interest in the eye prior to administration of study treatment

  Outcome Measures

1.  Primary:   Positive Culture   [ Time Frame: Study day 1, assessed following administration of study treatment ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

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
No text entered.

  More Information

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

Responsible Party: Christopher Ta, Stanford University 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: November 6, 2017