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Comparison of the Effect of 4th Generation Fluoroquinolones, Gatifloxacin and Moxifloxacin, on Epithelial Healing Following Photorefractive Keratectomy (PRK), A Substudy of: Initial Evaluation of Excimer Laser Keratorefractive Surgery in U.S. Army Personnel (WU # 2335-99)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00414011
First Posted: December 20, 2006
Last Update Posted: July 17, 2013
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:
Walter Reed Army Medical Center
Results First Submitted: April 1, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Epithelium, Corneal
Interventions: Drug: Moxifloxacin
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
Moxifloxacin/Gatifloxacin Treatment

Both eyes were treated. Each participant was randomly assigned to either:

Group A: Moxifloxacin eyedrops on right eye; Gatifloxacin eyedrops on left eye

Group B: Gatifloxacin eyedrops on right eye; Moxifloxacin eyedrops on left eye

Eyedrops were given as 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery


Participant Flow:   Overall Study
    Moxifloxacin/Gatifloxacin Treatment
STARTED   40 
COMPLETED   35 
NOT COMPLETED   5 
Physician Decision                3 
Withdrawal by Subject                2 



  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.
35 out of 40 participants had complete data for analysis.

Reporting Groups
  Description
Moxifloxacin/Gatifloxacin Treatment

Both eyes were treated. Each participant was randomly assigned to either:

Group A: Moxifloxacin eyedrops on right eye; Gatifloxacin eyedrops on left eye

Group B: Gatifloxacin eyedrops on right eye; Moxifloxacin eyedrops on left eye

Eyedrops were given as 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery


Baseline Measures
   Moxifloxacin/Gatifloxacin Treatment 
Overall Participants Analyzed 
[Units: Participants]
 35 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   35 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 33.7  (7) 
Gender 
[Units: Participants]
 
Female   16 
Male   19 
Region of Enrollment 
[Units: Participants]
 
United States   35 


  Outcome Measures

1.  Primary:   Corneal Epithelial Healing Time   [ Time Frame: 3 to 4 days after surgery ]


  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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Principal Investigator
Organization: U.S. Army Warfighter Refractive Surgery Research Center
phone: 571-231-1600
e-mail: rose.sia@us.army.mil



ClinicalTrials.gov Identifier: NCT00414011     History of Changes
Other Study ID Numbers: WRAMC WU # 04-2335-99e
First Submitted: December 19, 2006
First Posted: December 20, 2006
Results First Submitted: April 1, 2013
Results First Posted: June 26, 2013
Last Update Posted: July 17, 2013