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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):
Vistakon
ClinicalTrials.gov Identifier:
NCT00584831
First received: December 20, 2007
Last updated: September 21, 2011
Last verified: September 2011
History of Changes
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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Reporting Groups
  Description
Total Study Population No text entered.

Baseline Measures
    Total Study Population  
Number of Participants  
[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
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1.  Primary:   Visual Acuity After Infero-temporal Version Movement.   [ Time Frame: 10 minutes after insertion ]
  Show Outcome Measure 1

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

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

4.  Primary:   Visual Acuity After Superior-nasal Version Movement.   [ Time Frame: 10 minutes after lens insertion ]
  Show Outcome Measure 4


  Serious Adverse Events
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  Other Adverse Events
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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.


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.  


Results Point of Contact:  
Name/Title: Kurt Moody, OD, FAAO
Organization: Vistakon
phone: 904-443-3088
e-mail: kmoody1@its.jnj.com


No publications provided


Responsible Party: Vistakon
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: September 21, 2011
Health Authority: United Kingdom: Research Ethics Committee