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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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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Randomized, single center (Alcon Eye Clinic),

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Treatment randomization schedules were generated and maintained by the Alcon SAS Programming group. Only when the data were verified and validated and the database locked were the appropriate personnel unmasked.

Reporting Groups
  Description
TOBRADEX, Then Tob 0.3%/Dex 0.05%, Then TOBREX Patients received TOBRADEX first, then Tob 0.3%/Dex 0.05%, then TOBREX
Tob 0.3%/Dex 0.05%, Then TOBREX, Then TOBRADEX Patients received Tob 0.3%/Dex 0.05% first, then TOBREX, then TOBRADEX
TOBREX, Then TOBRADEX, Then Tob 0.3%/Dex 0.05% Patients received TOBREX first, then TOBRADEX, then Tob 0.3%/Dex 0.05%

Participant Flow:   Overall Study
    TOBRADEX, Then Tob 0.3%/Dex 0.05%, Then TOBREX     Tob 0.3%/Dex 0.05%, Then TOBREX, Then TOBRADEX     TOBREX, Then TOBRADEX, Then Tob 0.3%/Dex 0.05%  
STARTED     7     7     7  
COMPLETED     7     7     7  
NOT COMPLETED     0     0     0  



  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
  Show All Outcome Measures

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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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension
TOBREX® TOBREX® Ophthalmic Solution
TOBRADEX® TOBRADEX® Ophthalmic Suspension

Other Adverse Events
    Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension     TOBREX®     TOBRADEX®  
Total, other (not including serious) adverse events        
# participants affected / at risk     0/21     0/21     2/21  
Eye disorders        
Dry Eye †      
# participants affected / at risk     0/21 (0.00%)     0/21 (0.00%)     2/21 (9.52%)  
# events     0     0     2  
† Events were collected by systematic assessment



  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
No text entered.  


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