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Product Feasibility of a New Silicone Hydrogel Contact Lens

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01309100
First received: March 3, 2011
Last updated: March 27, 2014
Last verified: March 2014
Results First Received: March 27, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Single Blind (Subject)
Condition: Myopia
Interventions: Device: Investigational Lens
Device: Acuvue Oasys Lens
Device: Air Optix Aqua 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
This was a randomized, bilateral, three-way crossover, subject-masked study conducted at six sites in the United States. The first participant was enrolled 11/8/2010 and last participant exited on 12/23/2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
144 participants were equally randomized to one of six treatment sequences. 142 participants completed the study.

Reporting Groups
  Description
Overall Study Participants were equally randomized to one of 6 treatment sequences: RD2117-01, Air Optix Aqua, Acuvue Oasys; RD2117-01, Acuvue Oasys, Air Optix Aqua; Air Optix Aqua, RD2117-01, Acuvue Oasys; Air Optix Aqua, Acuvue Oasys, RD2117-01; Acuvue Oasys, RD2117-01, Air Optix Aqua; Acuvue Oasys, Air Optix Aqua, RD2117-01. All participants wore each of the 3 lenses for one week.

Participant Flow:   Overall Study
    Overall Study  
STARTED     144  
COMPLETED     142  
NOT COMPLETED     2  
Protocol Violation                 1  
Positive Slit lamp finding                 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.
All randomized participants

Reporting Groups
  Description
Overall Study Participants were equally randomized to one of 6 treatment sequences: RD2117-01, Air Optix Aqua, Acuvue Oasys; RD2117-01, Acuvue Oasys, Air Optix Aqua; Air Optix Aqua, RD2117-01, Acuvue Oasys; Air Optix Aqua, Acuvue Oasys, RD2117-01; Acuvue Oasys, RD2117-01, Air Optix Aqua; Acuvue Oasys, Air Optix Aqua, RD2117-01. All participants wore each of the 3 lenses for one week.

Baseline Measures
    Overall Study  
Number of Participants  
[units: participants]
  144  
Age  
[units: years]
Mean ± Standard Deviation
  30.6  ± 8.7  
Gender  
[units: participants]
 
Female     96  
Male     48  
Region of Enrollment  
[units: participants]
 
United States     144  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Visual Acuity (Investigational vs Air Optix Aqua Lens)   [ Time Frame: 1 week ]

2.  Primary:   Visual Acuity (Investigational vs Acuvue Oasys Lens)   [ Time Frame: 1 week ]

3.  Secondary:   Comfort Throughout the Day (Investigational vs Acuvue Oasys Lens)   [ Time Frame: 1 week ]

4.  Secondary:   Comfort Throughout the Day (Investigational vs Air Optix Aqua Lens)   [ Time Frame: 1 week ]


  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: Dr. Robert Steffen
Organization: Bausch & Lomb
phone: 585 338 6399
e-mail: robert.steffen@bausch.com


No publications provided


Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01309100     History of Changes
Other Study ID Numbers: 672E
Study First Received: March 3, 2011
Results First Received: March 27, 2014
Last Updated: March 27, 2014
Health Authority: United States: Food and Drug Administration