Dispensing Evaluation of New Daily Disposable Toric Soft Contact Lens.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT01055132
First received: January 22, 2010
Last updated: March 8, 2013
Last verified: March 2013
Results First Received: November 3, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Astigmatism
Interventions: Device: Etafilcon A toric contact lens
Device: Nelfilcon A toric contact lens

  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
One subject failed screening, and did not enter group assignment

Reporting Groups
  Description
Etafilcon A Toric Lens First/ Nelfilcon A Toric Lens Second Etafilcon A toric contact lens worn daily during first period of 5 - 9 days, then nelfilcon A toric contact lens worn daily during second period of 5 - 9 days
Nelfilcon A Toric Lens First/Etafilcon A Toric Lens Second Nelfilcon A toric contact lens worn daily during first period of 5 - 9 days, then etafilcon A toric contact lens worn daily during second period of 5 - 9 days

Participant Flow for 2 periods

Period 1:   Period 1 (5-9 Days)
    Etafilcon A Toric Lens First/ Nelfilcon A Toric Lens Second     Nelfilcon A Toric Lens First/Etafilcon A Toric Lens Second  
STARTED     36     33  
COMPLETED     35     33  
NOT COMPLETED     1     0  
unsatisfactory lens fitting performance                 1                 0  

Period 2:   Period 2 (5-9 Days)
    Etafilcon A Toric Lens First/ Nelfilcon A Toric Lens Second     Nelfilcon A Toric Lens First/Etafilcon A Toric Lens Second  
STARTED     35     33  
COMPLETED     35     32  
NOT COMPLETED     0     1  
Unsatisfactory lens fitting performance                 0                 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.
No text entered.

Reporting Groups
  Description
All Subjects All subjects who completed the study.

Baseline Measures
    All Subjects  
Number of Participants  
[units: participants]
  69  
Age  
[units: years]
Mean ± Standard Deviation
  29.1  ± 5.27  
Gender  
[units: participants]
 
Female     45  
Male     24  
Region of Enrollment  
[units: participants]
 
United States     69  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Monocular Visual Acuity on LogMAR Scale   [ Time Frame: After 5 to 9 days of lens wear ]

2.  Primary:   Binocular Visual Acuity on LogMAR Scale   [ Time Frame: After 5 to 9 days of lens wear ]

3.  Primary:   Subject Reported Overall Lens Comfort Using the Contact Lens User Evaluation (CLUE)TM Questionnaire   [ Time Frame: After 5 to 9 days of lens wear ]

4.  Primary:   Subject Reported Overall Quality of Vision Using the Contact Lens User Evaluation(CLUE)TM Questionnaire.   [ Time Frame: After 5 to 9 days of lens wear ]


  Serious Adverse Events


  Other Adverse Events


  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: Ross Franklin
Organization: Johnson & Johnson Vision Care
phone: 1-904-443-1379
e-mail: RFrankl1@its.jnj.com


No publications provided


Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT01055132     History of Changes
Other Study ID Numbers: CR-1476AG
Study First Received: January 22, 2010
Results First Received: November 3, 2011
Last Updated: March 8, 2013
Health Authority: United States: Institutional Review Board