Evaluation of CooperVision Avaira Toric (Enfilcon A) Soft Contact Lens When Compared to Acuvue Advance Toric Soft Contact Lens

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Coopervision, Inc.
ClinicalTrials.gov Identifier:
NCT01706770
First received: October 5, 2012
Last updated: March 28, 2014
Last verified: March 2014
Results First Received: October 22, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label
Condition: Ametropia
Interventions: Device: enfilcon A
Device: galyfilcon 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
52 subjects evaluated. Of these 52 subjects, 2 found ineligible and not randomized resulting in 50 subjects randomized, 33 test, 17 control. Of 50 subjects randomized, 2 discontinued and not included in results data, 31 test, 17 control, 1 lost to follow-up, 1 Sponsor/IRB decision due to pregnancy at one month visit.

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
Enfilcon A The test (experimental) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
Galyfilcon A The control (active comparator) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.

Participant Flow:   Overall Study
    Enfilcon A     Galyfilcon A  
STARTED     33     17  
COMPLETED     31     17  
NOT COMPLETED     2     0  
Lost to Follow-up                 1                 0  
Physician Decision                 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
Enfilcon A The test (experimental) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
Galyfilcon A The control (active comparator) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
Total Total of all reporting groups

Baseline Measures
    Enfilcon A     Galyfilcon A     Total  
Number of Participants  
[units: participants]
  33     17     50  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     33     17     50  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  34.8  ± 11.11     33.8  ± 11.50     34.4  ± 11.13  
Gender  
[units: participants]
     
Female     23     12     35  
Male     10     5     15  
Region of Enrollment  
[units: participants]
     
United States     33     17     50  



  Outcome Measures
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1.  Primary:   Objective Assessment: Ocular Response - Biomicroscopy   [ Time Frame: Change from baseline/dispensing visits, post-dispensing visit and all follow-ups visits ]

2.  Primary:   Comparison of Objective Findings - Number of Adverse Events in Unique Eyes   [ Time Frame: Any occurrence from baseline to 1 month visit ]


  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: William J. Gleason, O.D.
Organization: Foresight Regulatory Strategies, Inc.
phone: (978) 658-6888 ext 151


No publications provided


Responsible Party: Coopervision, Inc.
ClinicalTrials.gov Identifier: NCT01706770     History of Changes
Other Study ID Numbers: FC111216
Study First Received: October 5, 2012
Results First Received: October 22, 2013
Last Updated: March 28, 2014
Health Authority: United States: Food and Drug Administration