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Study of the Progression of Bacterial Conjunctivitis Symptoms Upon Antibiotic Treatment

This study has been completed.
Sponsor:
Collaborator:
Topical Solutions Ltd.
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00798577
First received: November 25, 2008
Last updated: March 30, 2010
Last verified: March 2010
History of Changes
Results First Received: March 2, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Bacterial Conjunctivitis
Interventions: Drug: Vigamox Ophthalmic Solution
Drug: BSS placebo

  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
Vigamox Vigamox Ophthalmic Solution (Moxifloxacin 5 mg/mL) three times daily for 7 days
Placebo Balanced Salt Solution (BSS) placebo for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days

Participant Flow:   Overall Study
    Vigamox     Placebo  
STARTED     17     7  
COMPLETED     17     7  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Vigamox Vigamox Ophthalmic Solution (Moxifloxacin 5 mg/mL) three times daily for 7 days
Placebo Balanced Salt Solution (BSS) placebo for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days
Total Total of all reporting groups

Baseline Measures
    Vigamox     Placebo     Total  
Number of Participants  
[units: participants]
 		  17     7     24  
Age  
[units: participants]
 		     
<=18 years     7     7     14  
Between 18 and 65 years     10     0     10  
>=65 years     0     0     0  
Gender  
[units: participants]
 		     
Female     11     5     16  
Male     6     2     8  



  Outcome Measures
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1.  Primary:   Exploratory Outcomes From Digital Photography   [ Time Frame: 24 hours after administration of first dose ]
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2.  Secondary:   Exploratory Evaluation of Changes in Ocular Signs and Symptoms   [ Time Frame: Baseline (Day 1) to Day 2 ]
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3.  Secondary:   Microbiological Culture Evaluation/Eradication Percent - Enterobacter Faecalis and Candida Albicans   [ Time Frame: 24 hours after administration of first dose ]
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4.  Secondary:   Microbiological Culture Evaluation/Eradication Percent - Eradication of All Other Isolates and Corynform-like   [ Time Frame: 24 hour after administration of first dose ]
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5.  Secondary:   Microbiological Culture Evaluation/Eradication Percent - Staphylococcus Aureus, Steptococcus Pneumoniae, and Enterobacter Cloacae   [ Time Frame: 24 hours after administration of first dose ]
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  Serious Adverse Events
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  Other Adverse Events
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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.


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
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Results Point of Contact:  
Name/Title: Alcon Clinical
Organization: Alcon Labs
phone: 1.888.451.3937; 817.568.6725
e-mail: medinfo@alconlabs.com


No publications provided


Responsible Party: Paul Cockrum, PhD, Director - Medical Affairs, Alcon Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00798577     History of Changes
Other Study ID Numbers: SMA-08-03
Study First Received: November 25, 2008
Results First Received: March 2, 2010
Last Updated: March 30, 2010
Health Authority: United States: Institutional Review Board