Comparison of Senofilcon A Toric Lenses to Balafilcon A Toric Lenses Over Extended Wear Period

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT00762502
First received: September 26, 2008
Last updated: May 6, 2015
Last verified: May 2015
Results First Received: March 28, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label
Condition: Astigmatism
Interventions: Device: senofilcon A toric contact lens
Device: balafilcon 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
Recruitment occurred at 1 site in the USA (n=50 enrolled), and 7 sites in Australia (n=62 enrolled)

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Total of 112 subjects enrolled, 77 subjects completed study after 3 months. The study was then restricted down to two sites (Australia only) after 3 months with only 37 of the 77 being included. There were 36 subjects whom completed the full 6 month trial period.

Reporting Groups
  Description
Senofilcon A Bilaterally Senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly. For those subject who continued the study from 3 months to 6 months, the same treatment was repeated.
Balafilcon A Bilaterally Balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly. For those subject who continued the study from 3 months to 6 months, the same treatment was repeated.
Senofilcon A Toric/Balafilcon A Toric Contralaterally Senofilcon A toric lens worn in one eye and Balafilcon A toric lens worn in the other eye (contralaterally), daily for 3 months, replaced weekly. For those subject who continued the study from 3 months to 6 months, the same treatment was repeated.

Participant Flow for 2 periods

Period 1:   Baseline to Month 3 (Period 1)
    Senofilcon A Bilaterally     Balafilcon A Bilaterally     Senofilcon A Toric/Balafilcon A Toric Contralaterally  
STARTED     36     25     51  
COMPLETED     26     19     32  
NOT COMPLETED     10     6     19  
Adverse Event                 4                 3                 6  
Lost to Follow-up                 6                 3                 13  

Period 2:   Month 3 to Month 6 (Period 2)
    Senofilcon A Bilaterally     Balafilcon A Bilaterally     Senofilcon A Toric/Balafilcon A Toric Contralaterally  
STARTED     9     5     23  
COMPLETED     9     4     23  
NOT COMPLETED     0     1     0  
Pregnancy                 0                 1                 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
Senofilcon A Toric Bilaterally senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly.
Balafilcon A Toric Bilaterally balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly.
Senofilcon A/Balafilcon A Contralaterally senofilcon A lens worn in one eye and balafilcon A lens worn in the other eye (contralaterally), daily for 3 months, replaced weekly.
Total Total of all reporting groups

Baseline Measures
    Senofilcon A Toric Bilaterally     Balafilcon A Toric Bilaterally     Senofilcon A/Balafilcon A Contralaterally     Total  
Number of Participants  
[units: participants]
  36     25     51     112  
Age  
[units: years]
Mean (Standard Deviation)
  29.8  (6.9)     30.4  (7.8)     29.6  (8.6)     29.8  (7.9)  
Gender  
[units: participants]
       
Female     25     19     35     79  
Male     11     6     16     33  
Region of Enrollment  
[units: participants]
       
United States     16     11     20     47  
Australia     20     14     31     65  



  Outcome Measures
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1.  Primary:   Corneal Staining   [ Time Frame: at 3 months of lens wear (period 1) ]

2.  Primary:   Limbal Redness   [ Time Frame: at 3 months of lens wear (period 1) ]

3.  Primary:   Bulbar Redness   [ Time Frame: at 3 months of lens wear (period 1) ]

4.  Primary:   Tarsal Roughness   [ Time Frame: at 3 months of lens wear (period 1) ]


  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: John Buch, OD
Organization: Johnson & Johnson Vision Care, Inc.
phone: 1-904-443-1707
e-mail: RA-Visus-ClnclStds@its.jnj.com


No publications provided


Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT00762502     History of Changes
Other Study ID Numbers: CR-4498
Study First Received: September 26, 2008
Results First Received: March 28, 2014
Last Updated: May 6, 2015
Health Authority: Australia: Human Research Ethics Committee