One Month Performance Comparison Between Two Commercially Available Silicone Hydrogel Lenses

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT01300741
First received: February 18, 2011
Last updated: June 26, 2012
Last verified: April 2012
Results First Received: April 11, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Single Blind (Subject);   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
  Hide Participant Flow

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
  Hide Baseline Characteristics

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  
Number of Participants  
[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
  Hide 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.


  More Information
  Hide More Information

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


No publications provided


Responsible Party: Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier: NCT01300741     History of Changes
Other Study ID Numbers: P-336-C-018
Study First Received: February 18, 2011
Results First Received: April 11, 2012
Last Updated: June 26, 2012
Health Authority: United States: Institutional Review Board