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Endothelial Bleb Response With Toric Lenses

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier:
NCT00630305
First received: February 28, 2008
Last updated: January 11, 2017
Last verified: January 2017
Results First Received: March 26, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single Blind (Participant);   Primary Purpose: Treatment
Condition: Ametropia
Interventions: Device: alphafilcon A toric
Device: lotrafilcon B toric
Device: senofilcon A toric

  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
Total of 37 subjects enrolled, with two being discontinued. Thirty-five (35) subjects were recruited to a single site, where eligibility was confirmed and informed consent discussed and when appropriate signed.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were randomized to go to all four sessions (A, B, C and D) in a random order. Once in a session subjects were further randomized to one of four contralteral lens sequences (right eye / left eye).

Reporting Groups
  Description
Overall subjects were randomized to a session (A, B, C and D) and then to one of four lens sequences. Each subject participated in every session.

Participant Flow:   Overall Study
    Overall
STARTED   37 
COMPLETED   35 
NOT COMPLETED   2 
Withdrawal by Subject                1 
Inability to insert contact lens                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.
All participants who were enrolled and randomized to a trial arm.

Reporting Groups
  Description
All Subjects All subjects who were enrolled, randomized, and assigned to a study arm.

Baseline Measures
   All Subjects 
Overall Participants Analyzed 
[Units: Participants]
 37 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      37 100.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 25.9  (7.7) 
Gender 
[Units: Participants]
Count of Participants
 
Female      25  67.6% 
Male      12  32.4% 
Region of Enrollment 
[Units: Participants]
 
Australia   37 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Endothelial Bleb Areas on Cornea: Session A- Open Eye   [ Time Frame: 20 minutes post-lens insertion ]

2.  Primary:   Endothelial Bleb Areas on Cornea: Session B- Closed Eye   [ Time Frame: 20 minutes post-lens insertion ]

3.  Primary:   Endothelial Bleb Areas on Cornea: Session C- Open Eye   [ Time Frame: 20 minutes post-lens insertion ]

4.  Primary:   Endothelial Bleb Areas on Cornea: Session D- Closed Eye   [ Time Frame: 20 minutes post-lens insertion ]


  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: Kurt Moody, OD
Organization: Johnson & Johnson Vision Care, Inc.
phone: 1-904-443-3088
e-mail: kmoody1@its.jnj.com



Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT00630305     History of Changes
Other Study ID Numbers: CR-0726
JJO0717
Study First Received: February 28, 2008
Results First Received: March 26, 2014
Last Updated: January 11, 2017