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Clinical Comparison of Silicone Hydrogel and HEMA-based Daily Disposable Contact Lenses

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT01362907
First received: May 27, 2011
Last updated: June 28, 2012
Last verified: June 2012
History of Changes
Results First Received: June 28, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Myopia
Interventions: Device: Delefilcon A contact lens
Device: Etafilcon A contact lens

  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
Participants were recruited from 4 US private practices.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Delefilcon A / Etafilcon A Delefilcon A contact lenses worn first, with etafilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
Etafilcon A / Delefilcon A Etafilcon A contact lenses worn first, with delefilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.

Participant Flow for 2 periods

 Period 1:   Period 1, One Week
    Delefilcon A / Etafilcon A     Etafilcon A / Delefilcon A  
STARTED     20     20  
COMPLETED     20     20  
NOT COMPLETED     0     0  

Period 2:   Period 2, One Week
    Delefilcon A / Etafilcon A     Etafilcon A / Delefilcon A  
STARTED     20     20  
COMPLETED     20     20  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Overall All enrolled participants

Baseline Measures
    Overall  
Number of Participants  
[units: participants]
 		  40  
Age  
[units: years]
Mean ± Standard Deviation 		  32.7  ± 9.5  
Gender  
[units: participants]
 		 
Female     29  
Male     11  
Region of Enrollment  
[units: participants]
 		 
United States     40  



  Outcome Measures
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1.  Primary:   Corrected Distance Monocular Visual Measurement Reported as Visual Acuity (VA)   [ Time Frame: 1 week of wear, replacing lenses daily ]
  Show Outcome Measure 1

2.  Primary:   Overall Comfort   [ Time Frame: 1 week of wear, replacing lenses daily ]
  Show Outcome Measure 2

3.  Primary:   Overall Vision Quality   [ Time Frame: 1 week of wear, replacing lenses daily ]
  Show Outcome Measure 3

4.  Primary:   Overall Handling   [ Time Frame: 1 week of wear, replacing lenses daily ]
  Show Outcome Measure 4

5.  Secondary:   Overall Lens Fit   [ Time Frame: 1 week of wear, replacing lenses daily ]
  Show Outcome Measure 5


  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
No text entered.  


Results Point of Contact:  
Name/Title: Joachim Nick, Dipl. Ing. (FH)
Organization: Alcon Research
phone: +49 6022 240 520
e-mail: joachim.nick@cibavision.com


No publications provided


Responsible Party: Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier: NCT01362907     History of Changes
Other Study ID Numbers: P-347-C-013
Study First Received: May 27, 2011
Results First Received: June 28, 2012
Last Updated: June 28, 2012
Health Authority: United States: Institutional Review Board