Clinical Performance Comparison of Several Different Contact Lenses

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT00912028
First received: May 29, 2009
Last updated: March 27, 2014
Last verified: March 2014
Results First Received: March 27, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Myopia
Interventions: Device: senofilcon A
Device: lotrafilcon B
Device: balafilcon A
Device: methafilcon A
Device: vifilcon A

  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
Senofilcon A

contact lens

senofilcon A: contact lens

Lotrafilcon B

contact lens

lotrafilcon B: contact lens

Balafilcon A

contact lens

balafilcon A: contact lens

Methafilcon A

contact lens

methafilcon A: contact lens

Vifilcon A

contact lens

vifilcon A: contact lens


Participant Flow:   Overall Study
    Senofilcon A     Lotrafilcon B     Balafilcon A     Methafilcon A     Vifilcon A  
STARTED     35     3     13     17     3  
COMPLETED     30     0     13     16     0  
NOT COMPLETED     5     3     0     1     3  
Lost to Follow-up                 2                 3                 0                 1                 3  
Withdrawal by Subject                 3                 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.
This population includes those who were qualified to be in the analysis population. Demographics are not available for those who were excluded or discontinued.

Reporting Groups
  Description
Senofilcon A

contact lens

senofilcon A: contact lens

Balafilcon A

contact lens

balafilcon A: contact lens

Methafilcon A

contact lens

methafilcon A: contact lens

Total Total of all reporting groups

Baseline Measures
    Senofilcon A     Balafilcon A     Methafilcon A     Total  
Number of Participants  
[units: participants]
  30     13     16     59  
Age  
[units: years]
Mean ± Standard Deviation
  23.9  ± 3.9     22.7  ± 3.5     27.0  ± 4.2     24.5  ± 4.2  
Gender  
[units: participants]
       
Female     26     7     13     46  
Male     4     6     3     13  
Region of Enrollment  
[units: participants]
       
Brazil     30     13     16     59  



  Outcome Measures
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1.  Primary:   Limbal Hyperemia (Redness)   [ Time Frame: 2 weeks ]

2.  Primary:   Limbal Hyperemia (Redness)   [ Time Frame: 4 weeks ]

3.  Primary:   Bulbar Hyperemia (Redness)   [ Time Frame: 2 weeks ]

4.  Primary:   Bulbar Hyperemia (Redness)   [ Time Frame: 4 weeks ]

5.  Primary:   Corneal Staining   [ Time Frame: 2 weeks ]

6.  Primary:   Corneal Staining   [ Time Frame: 4 weeks ]


  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 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: Carlos E Leite Arieta MD, PhD
Organization: University of Campinas, Brazil
e-mail: ra-visus-clnclstds@its.jnj.com


No publications provided


Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT00912028     History of Changes
Other Study ID Numbers: AOH--BRA-001
Study First Received: May 29, 2009
Results First Received: March 27, 2014
Last Updated: March 27, 2014
Health Authority: Brazil: Ethics Committee