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Clinical Evaluation of Two Daily Disposable Silicone Hydrogel Contact Lenses

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01561560
First received: March 21, 2012
Last updated: November 19, 2013
Last verified: November 2013
Results First Received: November 19, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Myopia
Interventions: Device: Delefilcon A contact lenses
Device: Narafilcon A contact lenses

  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 two study centers in Finland, three study centers in German, and three study centers in the UK.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 123 participants enrolled, two were excluded prior to randomization. This reporting group includes all participants enrolled and exposed to Test Article (121).

Reporting Groups
  Description
DAILIES TOTAL1, Then TRUEYE Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks.
TRUEYE, Then DAILIES TOTAL1 Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks.

Participant Flow for 2 periods

Period 1:   First Two Weeks of Wear
    DAILIES TOTAL1, Then TRUEYE     TRUEYE, Then DAILIES TOTAL1  
STARTED     60     61  
COMPLETED     60     59  
NOT COMPLETED     0     2  
Time/job conflict                 0                 1  
Adverse Event                 0                 1  

Period 2:   Second Two Weeks of Wear
    DAILIES TOTAL1, Then TRUEYE     TRUEYE, Then DAILIES TOTAL1  
STARTED     60     59  
COMPLETED     60     58  
NOT COMPLETED     0     1  
Adverse Event                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants enrolled and exposed to Test Article

Reporting Groups
  Description
OVERALL Delefilcon A contact lenses and narafilcon A contact lenses worn in randomized order. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks.

Baseline Measures
    OVERALL  
Number of Participants  
[units: participants]
  121  
Age  
[units: years]
Mean ± Standard Deviation
  34.0  ± 10.4  
Gender  
[units: participants]
 
Female     85  
Male     36  



  Outcome Measures

1.  Primary:   End-of-day Comfort   [ Time Frame: Week 2 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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.


  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.


Results Point of Contact:  
Name/Title: Jami Kern, PhD
Organization: Alcon Research, Ltd.
phone: 1-888-451-3937
e-mail: alcon.medinfo@alcon.com


No publications provided


Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01561560     History of Changes
Other Study ID Numbers: P-347-C-019
Study First Received: March 21, 2012
Results First Received: November 19, 2013
Last Updated: November 19, 2013
Health Authority: United Kingdom: Research Ethics Committee
Finland: Ethics Committee
Germany: Ethics Commission