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Tobramycin Tear Concentrations

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00695435
First received: June 9, 2008
Last updated: February 23, 2010
Last verified: February 2010
History of Changes
Results First Received: April 27, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Dry Eye
Interventions: Drug: TOBRADEX Ophthalmic Suspension
Drug: Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension
Drug: TOBREX Ophthalmic Solution

  Participant Flow
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  Baseline Characteristics
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Reporting Groups
  Description
Overall Study Overall Study

Baseline Measures
    Overall Study  
Number of Participants  
[units: participants]
 		  21  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     21  
>=65 years     0  
Gender  
[units: participants]
 		 
Female     17  
Male     4  



  Outcome Measures
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1.  Primary:   Tobramycin Tear Concentration Cmax (Maximum Concentration)   [ Time Frame: 2, 4, 6, 12, and 18 minutes ]
  Show Outcome Measure 1

2.  Secondary:   Tobramycin Tear Concentration Area Under the Curve (AUC)   [ Time Frame: 2 to 18 minutes post administration ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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 Research, LTD
phone: 888.451.3937; 817.568.6725
e-mail: medinfo@alconlabs.com


No publications provided


Responsible Party: Michael Brubaker, Alcon
ClinicalTrials.gov Identifier: NCT00695435     History of Changes
Other Study ID Numbers: C-08-33
Study First Received: June 9, 2008
Results First Received: April 27, 2009
Last Updated: February 23, 2010
Health Authority: United States: Food and Drug Administration