Effect of Head and Gaze Position on Soft Toric Contact Lens Performance

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT01579045
First received: April 13, 2012
Last updated: September 29, 2014
Last verified: September 2014
Results First Received: August 28, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Conditions: Astigmatism
Myopia
Interventions: Device: senofilcon A
Device: etafilcon A
Device: nelfilcon A
Device: Filcon II 3

  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
Subjects were recruited and screened based on the inclusion/exclusion criteria.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
All Subjects All subjects who were enrolled.

Participant Flow:   Overall Study
    All Subjects  
STARTED     24  
COMPLETED     24  
NOT COMPLETED     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.
Twenty-four subjects were screened, enrolled and completed each of the two arms of the study. No subjects were deemed ineligible on screening.

Reporting Groups
  Description
Overall Subjects All subjects who were enrolled, and completed the study.

Baseline Measures
    Overall Subjects  
Number of Participants  
[units: participants]
  24  
Age  
[units: years]
Mean ± Standard Deviation
  43.2  ± 15.3  
Gender  
[units: participants]
 
Female     21  
Male     3  
Region of Enrollment  
[units: participants]
 
United Kingdom     24  



  Outcome Measures
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1.  Primary:   Lens Orientation in Recumbent Position   [ Time Frame: up to 60 minutes in recumbent position ]

2.  Secondary:   Monocular Visual Acuity in Recumbent Position   [ Time Frame: up to 60 minutes in recumbent position ]


  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 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: Katherine Osborn Lorenz, OD MS
Organization: Vistakon/Johnson & Johnson Vision Care
phone: 904-443-3123
e-mail: kosborn@its.jnj.com


No publications provided


Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT01579045     History of Changes
Other Study ID Numbers: CR-005141
Study First Received: April 13, 2012
Results First Received: August 28, 2014
Last Updated: September 29, 2014
Health Authority: United Kingdom: National Health Service