ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of Daytime Corneal Swelling During Wear of Galyfilcon A Lenses

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.
ClinicalTrials.gov Identifier: NCT01482819
Recruitment Status : Completed
First Posted : December 1, 2011
Results First Posted : April 30, 2015
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition: Myopia
Interventions: Device: galyfilcon A
Device: galyfilcon A plus
Device: lotrafilcon A
Device: polymacon
Other: spectacles

  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
All Subjects Twenty-one subjects were enrolled, and 19 subjects completed the study per protocol. Two subjects were discontinued. There were no ineligible subjects.

Participant Flow:   Overall Study
    All Subjects
STARTED   21 
COMPLETED   19 
NOT COMPLETED   2 
Lost to Follow-up                2 



  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.
Subjects who were screened, gave consent, enrolled, and were randomized in the study.

Reporting Groups
  Description
All Subjects Twenty-one subjects were enrolled, and 19 subjects completed the study per protocol. Two subjects were discontinued. There were no ineligible subjects.

Baseline Measures
   All Subjects 
Overall Participants Analyzed 
[Units: Participants]
 21 
Age 
[Units: Years]
Mean (Standard Deviation)
 23.7  (6.11) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      15  71.4% 
Male      6  28.6% 
Race/Ethnicity, Customized 
[Units: Participants]
 
Asian   5 
Multiple   16 
Region of Enrollment 
[Units: Participants]
 
Australia   21 


  Outcome Measures

1.  Primary:   Corneal Swelling   [ Time Frame: after 8 hours of lens wear ]

2.  Primary:   Limbal Redness   [ Time Frame: after 8 hours of lens wear ]

3.  Primary:   Endothelia Blebs   [ Time Frame: after 20 minutes of lens wear ]


  Serious Adverse Events


  Other Adverse Events


  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

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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Daria Wicks, Senior Clinical Research Manager
Organization: Johnson & Johnson Vision Care
phone: 904-443-1391
e-mail: RA-ClnclStds@its.jnj.com



Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT01482819     History of Changes
Other Study ID Numbers: CR-005031
First Submitted: November 16, 2011
First Posted: December 1, 2011
Results First Submitted: January 8, 2015
Results First Posted: April 30, 2015
Last Update Posted: June 19, 2018