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Performance of Two Silicone Hydrogel Toric Contact Lenses

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT00638846
First received: March 10, 2008
Last updated: September 28, 2011
Last verified: September 2011
History of Changes
Results First Received: June 18, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Vision Correction
Interventions: Device: senofilcon A toric
Device: balafilcon A toric

  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
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Reporting Groups
  Description
Senofilcon A Toric senofilcon A toric contact lens. Analysis includes participants that completed the study.
Balafilcon A Toric balafilcon A toric contact lens. Analysis includes participants that completed the study.

Participant Flow:   Overall Study
    Senofilcon A Toric     Balafilcon A Toric  
STARTED     137     139  
COMPLETED     133     133  
NOT COMPLETED     4     6  
Adverse Event                 0                 1  
Lost to Follow-up                 3                 2  
lens issue                 1                 3  



  Baseline Characteristics
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Reporting Groups
  Description
Senofilcon A Toric senofilcon A toric contact lens. Analysis includes participants that completed the study.
Balafilcon A Toric balafilcon A toric contact lens. Analysis includes participants that completed the study.
Total Total of all reporting groups

Baseline Measures
    Senofilcon A Toric     Balafilcon A Toric     Total  
Number of Participants  
[units: participants]
 		  137     139     276  
Age  
[units: years]
Mean ± Standard Deviation 		  29.81  ± 6.99     30.13  ± 7.69     29.97  ± 7.33  
Gender [1]
[units: participants]
 		     
Female     91     92     183  
Male     46     45     91  
[1] Gender of 2 subjects assigned to balafilcon A is unknown.



  Outcome Measures
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1.  Primary:   Lens Orientation   [ Time Frame: 1 minute after insertion ]
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2.  Primary:   Lens Stability   [ Time Frame: 10-15 minutes after insertion ]
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3.  Primary:   Subjective Comfort   [ Time Frame: 2 weeks of lens wear ]
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4.  Secondary:   Time to Fit Lens   [ Time Frame: after lens insertion ]
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5.  Secondary:   Subjective Lens Vision   [ Time Frame: measured at 1 and 2 weeks ]
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6.  Secondary:   Overall Corneal Staining   [ Time Frame: After 2 weeks use ]
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  Serious Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Reporting Groups
  Description
Senofilcon A Toric senofilcon A toric contact lens. Analysis includes participants that completed the study.
Balafilcon A Toric balafilcon A toric contact lens. Analysis includes participants that completed the study.

Serious Adverse Events
    Senofilcon A Toric     Balafilcon A Toric  
Total, serious adverse events      
# participants affected / at risk     0/133 (0.00%)     0/133 (0.00%)  




  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
No text entered.  


Results Point of Contact:  
Name/Title: Kurt Moody OD
Organization: Vistakon
phone: 904-443-3088


No publications provided


Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT00638846     History of Changes
Other Study ID Numbers: CR-0801, CTOR-501
Study First Received: March 10, 2008
Results First Received: June 18, 2010
Last Updated: September 28, 2011
Health Authority: United States: Food and Drug Administration