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One Month Performance Comparison Between Two Commercially Available Silicone Hydrogel Lenses

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01300741
First Posted: February 23, 2011
Last Update Posted: July 10, 2012
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 ( CIBA VISION )
Results First Submitted: April 11, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition: Myopia
Interventions: Device: Lotrafilcon B contact lens (AIR OPTIX® AQUA)
Device: Galyfilcon A contact lens (ACUVUE® ADVANCE® Plus)
Device: Contact lens solution (Clear Care®)

  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 5 US study centers.

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
Lotrafilcon B / Galyfilcon A Lotrafilcon B commercially marketed contact lens randomly assigned to one eye, with galyfilcon A commercially marketed contact lens in the fellow eye for contralateral wear. Lenses were worn in a daily wear (DW) modality for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks.

Participant Flow:   Overall Study
    Lotrafilcon B / Galyfilcon A
STARTED   75 
COMPLETED   72 
NOT COMPLETED   3 
Lens deposits                1 
Lost to Follow-up                1 
Discomfort                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.
No text entered.

Reporting Groups
  Description
Lotrafilcon B / Galyfilcon A Lotrafilcon B commercially marketed contact lens randomly assigned to one eye, with galyfilcon A commercially marketed contact lens in the fellow eye for contralateral wear. Lenses were worn in a daily wear (DW) modality for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks.

Baseline Measures
   Lotrafilcon B / Galyfilcon A 
Overall Participants Analyzed 
[Units: Participants]
 75 
Age 
[Units: Years]
Mean (Standard Deviation)
 30.9  (9.2) 
Gender 
[Units: Participants]
 
Female   53 
Male   22 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Comfort on Insertion   [ Time Frame: 4 weeks ]

2.  Primary:   Comfort During the Day   [ Time Frame: 4 weeks ]

3.  Primary:   Comfort at End of Day   [ Time Frame: 4 weeks ]

4.  Primary:   Overall Comfort   [ Time Frame: 4 weeks ]

5.  Primary:   Daytime Vision   [ Time Frame: 4 weeks ]

6.  Primary:   Low Light Vision   [ Time Frame: 4 weeks ]

7.  Primary:   Handling on Insertion   [ Time Frame: 4 weeks ]

8.  Primary:   Handling at Removal   [ Time Frame: 4 weeks ]

9.  Primary:   Delivers a Healthy, Natural Feeling   [ Time Frame: 4 weeks ]

10.  Primary:   Lens Awareness   [ Time Frame: 4 weeks ]

11.  Primary:   Overall Satisfaction   [ Time Frame: 4 weeks ]

12.  Primary:   Purchase Intent   [ Time Frame: 4 weeks ]


  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: Director of Clinical Trials
Organization: Alcon Research
phone: 1-800-241-7629



Responsible Party: Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier: NCT01300741     History of Changes
Other Study ID Numbers: P-336-C-018
First Submitted: February 18, 2011
First Posted: February 23, 2011
Results First Submitted: April 11, 2012
Results First Posted: May 9, 2012
Last Update Posted: July 10, 2012