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Visual Performance Investigation of Two Toric Soft Contact Lenses (CARDINAL)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01858701
First Posted: May 21, 2013
Last Update Posted: October 22, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alcon Research
Results First Submitted: October 17, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions: Refractive Error
Astigmatism
Myopia
Hyperopia
Interventions: Device: Lotrafilcon B toric contact lens
Device: Comfilcon A toric 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 1 study center located in Canada.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 49 enrolled, 9 participants were exited as screen failures prior to randomization. This reporting group includes all randomized participants (40).

Reporting Groups
  Description
AO for Astig / Biofinity Toric Lotrafilcon B toric contact lenses worn in Period 1, followed by comfilcon A toric contact lenses in Period 2.
Biofinity Toric / AO for Astig Comfilcon A toric contact lenses worn in Period 1, followed by lotrafilcon B toric contact lenses in Period 2.

Participant Flow for 3 periods

Period 1:   Period 1, First 30 Days of Wear
    AO for Astig / Biofinity Toric   Biofinity Toric / AO for Astig
STARTED   20   20 
COMPLETED   20   19 
NOT COMPLETED   0   1 
Withdrawal by Subject                0                1 

Period 2:   Washout Period, 1-13 Days
    AO for Astig / Biofinity Toric   Biofinity Toric / AO for Astig
STARTED   20   19 
COMPLETED   18   17 
NOT COMPLETED   2   2 
Inclusion/Exclusion Criteria Not Met                1                0 
Withdrawal by Subject                1                2 

Period 3:   Period 2, Second 30 Days of Wear
    AO for Astig / Biofinity Toric   Biofinity Toric / AO for Astig
STARTED   18   17 
COMPLETED   18   16 
NOT COMPLETED   0   1 
Comfort                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.
This analysis population includes all enrolled participants.

Reporting Groups
  Description
Overall Lotrafilcon B toric contact lenses and comfilcon A toric contact lenses worn during Period 1 and Period 2 in a crossover assignment.

Baseline Measures
   Overall 
Overall Participants Analyzed 
[Units: Participants]
 49 
Age 
[Units: Years]
Mean (Standard Deviation)
 28  (8.2) 
Gender 
[Units: Participants]
 
Female   36 
Male   13 


  Outcome Measures

1.  Primary:   Mean Ocular Coma Score at 5mm Pupil at Day 30   [ Time Frame: Day 30 ]


  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
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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.


Results Point of Contact:  
Name/Title: Jessie Lemp, GMA Brand Lead
Organization: Alcon Research, Ltd.
phone: 1-888-451-3937
e-mail: alcon.medinfo@alcon.com



Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01858701     History of Changes
Other Study ID Numbers: A01335
P/438/13/L
First Submitted: May 17, 2013
First Posted: May 21, 2013
Results First Submitted: October 17, 2014
Results First Posted: October 22, 2014
Last Update Posted: October 22, 2014