We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Performance Comparison of Two Contact Lenses

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00975585
First Posted: September 11, 2009
Last Update Posted: September 28, 2017
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.
Collaborator:
Visioncare Research Ltd.
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.
Results First Submitted: February 18, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition: Myopia
Interventions: Device: senofilcon A
Device: lotrafilcon B

  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
No text entered.

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
Senofilcon A contact lens
Lotrafilcon B contact lens

Participant Flow:   Overall Study
    Senofilcon A   Lotrafilcon B
STARTED   184   195 
COMPLETED   177   183 
NOT COMPLETED   7   12 
Adverse Event                0                4 
Lost to Follow-up                3                5 
Withdrawal by Subject                2                1 
Lens issue                2                2 



  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
Senofilcon A contact lens
Lotrafilcon B contact lens
Total Total of all reporting groups

Baseline Measures
   Senofilcon A   Lotrafilcon B   Total 
Overall Participants Analyzed 
[Units: Participants]
 184   195   379 
Age 
[Units: Years]
Mean (Standard Deviation)
 29.7  (7.0)   29.3  (6.9)   29.5  (6.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      125  67.9%      136  69.7%      261  68.9% 
Male      59  32.1%      59  30.3%      118  31.1% 
Region of Enrollment 
[Units: Participants]
     
United States   184   195   379 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Average Corneal Staining   [ Time Frame: 2 weeks ]

2.  Primary:   Visual Acuity   [ Time Frame: 2 weeks ]

3.  Primary:   Overall Comfort   [ Time Frame: 2 weeks ]

4.  Primary:   Overall Comfort   [ Time Frame: 2 weeks and 4 weeks ]

5.  Secondary:   Limbal Redness   [ Time Frame: 2 weeks ]

6.  Secondary:   Bulbar Redness   [ Time Frame: 2 weeks ]

7.  Secondary:   Symptoms of Dryness   [ Time Frame: 2 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: Sheila Hickson-Curran, MCOptom/ Director, Medical Affairs
Organization: Vistakon
phone: 904-443-1754



Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT00975585     History of Changes
Other Study ID Numbers: CR-0907
PHNX-518
First Submitted: September 10, 2009
First Posted: September 11, 2009
Results First Submitted: February 18, 2011
Results First Posted: March 22, 2011
Last Update Posted: September 28, 2017