A Study to Evaluate the Safety and Efficacy of Gatifloxacin for the Treatment of Bacterial Conjunctivitis

This study has been completed.
Sponsor:
Information provided by:
Allergan
ClinicalTrials.gov Identifier:
NCT00464438
First received: April 19, 2007
Last updated: August 17, 2011
Last verified: August 2011
Results First Received: June 15, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Bacterial Conjunctivitis
Interventions: Drug: gatifloxacin
Drug: moxifloxacin 0.5% eye drops

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Gatifloxacin 0.3% No text entered.
Moxifloxacin 0.5% No text entered.

Participant Flow:   Overall Study
    Gatifloxacin 0.3%     Moxifloxacin 0.5%  
STARTED     85     86  
COMPLETED     83     80  
NOT COMPLETED     2     6  



  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.
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Reporting Groups
  Description
Gatifloxacin 0.3% No text entered.
Moxifloxacin 0.5% No text entered.
Total Total of all reporting groups

Baseline Measures
    Gatifloxacin 0.3%     Moxifloxacin 0.5%     Total  
Number of Participants  
[units: participants]
  85     86     171  
Age  
[units: days]
Mean ± Standard Deviation
  15.2  ± 6.59     15.2  ± 6.05     15.2  ± 6.31  
Gender  
[units: participants]
     
Female     37     22     59  
Male     48     64     112  



  Outcome Measures
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1.  Primary:   Percentage of Patients With Clearing (Clinical Success) of Conjunctival Erythema and Conjunctival Discharge at Day 7   [ Time Frame: Day 7 ]

2.  Secondary:   Percentage of Patients With Microbiological Improvement   [ Time Frame: Day 7 ]

3.  Secondary:   Percentage of Patients With Improvement in Ocular Signs for Lid Erythema   [ Time Frame: Days 7 ]

4.  Secondary:   Percentage of Patients With Improvement in Ocular Signs for Conjunctival Discharge at Day 7   [ Time Frame: Day 7 ]


  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: Therapeutic Area Head
Organization: Allergan, Inc.
phone: (714) 246-4500
e-mail: clinicaltrials@allergan.com


No publications provided


Responsible Party: Therapeutic Area Head, Allergan, Inc.
ClinicalTrials.gov Identifier: NCT00464438     History of Changes
Other Study ID Numbers: 198782-003
Study First Received: April 19, 2007
Results First Received: June 15, 2010
Last Updated: August 17, 2011
Health Authority: United States: Food and Drug Administration