Effect of Eye Movement on Toric Lens Orientation and Visual Acuity

This study has been completed.
Sponsor:
Collaborator:
University of Manchester
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier:
NCT00584831
First received: December 20, 2007
Last updated: May 5, 2015
Last verified: May 2015
Results First Received: September 24, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Astigmatism
Interventions: Device: senofilcon A
Device: balafilcon A
Device: omafilcon A
Device: lotrafilcon B

  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
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
Group1 LSOB lotrafilcon b toric, senofilcon A toric, omafilcon A toric, balafilcon A toric
Group 2 LSBO lotrafilcon B toric, senofilcon A toric, balafilcon A toric, omafilcon A toric
Group 4 LBSO lotrafilcon B toric, balafilcon A toric, senofilcon A toric, omafilcon A toric
Group 5 LBOS lotrafilcon B toric, balafilcon A toric, omafilcon A toric, senofilcon A
Group 7 SLBO senofilcon A toric, lotrafilcon B toric, balafilcon A toric, omafilcon A toric
Group 8 SOLB senofilcon A toric, omafilcon A toric, lotrafilcon B toric, balafilcon A toric
Group 9 SBLO senofilcon A toric, balafilcon A toric, lotrafilcon B toric, omafilcon A toric
Group 10 SBOL senofilcon A toric, balafilcon A toric, omafilcon A toric, lotrafilcon B toric
Group 11 OSLB omafilcon A toric, senofilcon A toric, lotrafilcon B toric, balafilcon A toric
Group 12 OSBL omafilcon A toric, senofilcon A toric, balafilcon A toric, lotrafilcon B toric
Group 13 OBLS omafilcon A toric, balafilcon A toric, lotrafilcon B toric, senofilcon A toric
Group 14 OBSL omafilcon A toric, balafilcon A toric, senofilcon A toric, lotrafilcon B toric
Group 15 BLSO balafilcon A toric, lotrafilcon B toric, senofilcon A toric, omafilcon A toric
Group 16 BLOS balafilcon A toric, lotrafilcon B toric, omafilcon A toric, senofilcon A toric
Group 18 BOLS balafilcon A toric, omafilcon A toric, lotrafilcon B toric, senofilcon A toric
Group 19 BOSL balafilcon A toric, omafilcon A toric, senofilcon A toric, lotrafilcon B toric
Group 3 LOSB lotrafilcon B toric, omafilcon A toric, senofilcon A toric, balafilcon A toric
Group 6 SLOB senofilcon A toric, lotrafilcon b toric, omafilcon A toric, balafilcon A toric
Group 17 BSOL balafilcon A toric, senofilcon A toric,omafilcon A toric, lotrafilcon b toric

Participant Flow for 4 periods

Period 1:   Intervention 1
    Group1 LSOB   Group 2 LSBO   Group 4 LBSO   Group 5 LBOS   Group 7 SLBO   Group 8 SOLB   Group 9 SBLO   Group 10 SBOL   Group 11 OSLB   Group 12 OSBL   Group 13 OBLS   Group 14 OBSL   Group 15 BLSO   Group 16 BLOS   Group 18 BOLS   Group 19 BOSL   Group 3 LOSB   Group 6 SLOB   Group 17 BSOL
STARTED   1   3   2   1   2   1   6   2   4   2   2   1   2   1   3   1   4   1   1 
COMPLETED   1   3   2   1   2   1   6   2   4   2   2   1   2   1   3   1   4   1   1 
NOT COMPLETED   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0 

Period 2:   Intervention 2
    Group1 LSOB   Group 2 LSBO   Group 4 LBSO   Group 5 LBOS   Group 7 SLBO   Group 8 SOLB   Group 9 SBLO   Group 10 SBOL   Group 11 OSLB   Group 12 OSBL   Group 13 OBLS   Group 14 OBSL   Group 15 BLSO   Group 16 BLOS   Group 18 BOLS   Group 19 BOSL   Group 3 LOSB   Group 6 SLOB   Group 17 BSOL
STARTED   1   3   2   1   2   1   6   2   4   2   2   1   2   1   3   1   4   1   1 
COMPLETED   1   3   2   1   2   1   6   2   4   2   2   1   2   1   3   1   4   1   1 
NOT COMPLETED   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0 

Period 3:   Intervention 3
    Group1 LSOB   Group 2 LSBO   Group 4 LBSO   Group 5 LBOS   Group 7 SLBO   Group 8 SOLB   Group 9 SBLO   Group 10 SBOL   Group 11 OSLB   Group 12 OSBL   Group 13 OBLS   Group 14 OBSL   Group 15 BLSO   Group 16 BLOS   Group 18 BOLS   Group 19 BOSL   Group 3 LOSB   Group 6 SLOB   Group 17 BSOL
STARTED   1   3   2   1   2   1   6   2   4   2   2   1   2   1   3   1   4   1   1 
COMPLETED   1   3   2   1   2   1   6   2   4   2   2   1   2   1   3   1   4   1   1 
NOT COMPLETED   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0 

Period 4:   Intervention 4
    Group1 LSOB   Group 2 LSBO   Group 4 LBSO   Group 5 LBOS   Group 7 SLBO   Group 8 SOLB   Group 9 SBLO   Group 10 SBOL   Group 11 OSLB   Group 12 OSBL   Group 13 OBLS   Group 14 OBSL   Group 15 BLSO   Group 16 BLOS   Group 18 BOLS   Group 19 BOSL   Group 3 LOSB   Group 6 SLOB   Group 17 BSOL
STARTED   1   3   2   1   2   1   6   2   3   2   2   1   2   1   2   1   4   1   1 
COMPLETED   1   3   2   1   2   1   6   2   3   2   2   1   2   1   2   1   4   1   1 
NOT COMPLETED   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0 



  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
Total Study Population No text entered.

Baseline Measures
   Total Study Population 
Overall Participants Analyzed 
[Units: Participants]
 40 
Age 
[Units: Years]
Mean (Standard Deviation)
 28.3  (7.9) 
Gender 
[Units: Participants]
 
Female   28 
Male   12 
Region of Enrollment 
[Units: Participants]
 
United Kingdom   40 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Visual Acuity After Infero-temporal Version Movement.   [ Time Frame: 10 minutes after insertion ]

2.  Primary:   Visual Acuity After Infero-nasal Version Movement.   [ Time Frame: 10 minutes after lens insertion ]

3.  Primary:   Visual Acuity After Superior-temporal Version Movement   [ Time Frame: 10 minutes after lens insertion ]

4.  Primary:   Visual Acuity After Superior-nasal Version Movement.   [ Time Frame: 10 minutes after 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
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: Kurt Moody, OD, FAAO
Organization: Vistakon
phone: 904-443-3088
e-mail: kmoody1@its.jnj.com



Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT00584831     History of Changes
Other Study ID Numbers: CR-0725
J07-416
Study First Received: December 20, 2007
Results First Received: September 24, 2009
Last Updated: May 5, 2015