A Study to Evaluate a New Silicone Hydrogel Contact Lens

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01309893
First received: March 4, 2011
Last updated: November 20, 2014
Last verified: November 2014
Results First Received: November 4, 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: 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
Participants recruited for this 2-week study conducted at three investigational sites in the USA. The first participant was enrolled on 12/17/2010; the last participant exited the study on 01/20/2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
66 participants enrolled; 64 participants completed. Half wore Investigational Lens for 1 week then crossed over to Air Optix Aqua lens for 1 week. The other half wore Air Optix Aqua Lens for 1 week then crossed over to Investigational Lens for 1 week. The order of lens use was randomized and participant-masked.

Reporting Groups
  Description
Investigational Lens First, Then Air Optix Aqua Lens Enrolled participants spent 1 week using Investigational Lens, and then crossed over to 1 week using Air Optix Aqua lens. The order of contact lens use was randomized and participant-masked.
Air Optix Aqua Lens First, Then Investigational Lens Enrolled participants spent 1 week using Air Optix Aqua Lens, and then crossed over to 1 week using Investigational Lens. The order of contact lens use was randomized and participant-masked.

Participant Flow for 2 periods

Period 1:   Week 1 - First Intervention
    Investigational Lens First, Then Air Optix Aqua Lens     Air Optix Aqua Lens First, Then Investigational Lens  
STARTED     33     33  
COMPLETED     33     33  
NOT COMPLETED     0     0  

Period 2:   Week 2 - Crossover Intervention
    Investigational Lens First, Then Air Optix Aqua Lens     Air Optix Aqua Lens First, Then Investigational Lens  
STARTED     33     33  
COMPLETED     32     32  
NOT COMPLETED     1     1  
Lost to Follow-up                 1                 0  
Missed crossover visit                 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.
All eligible enrolled participants

Reporting Groups
  Description
Entire Study Population All eligible enrolled participants

Baseline Measures
    Entire Study Population  
Number of Participants  
[units: participants]
  66  
Age  
[units: years]
Mean (Standard Deviation)
  29.6  (9.4)  
Gender  
[units: participants]
 
Female     52  
Male     14  
Region of Enrollment  
[units: participants]
 
United States     66  



  Outcome Measures
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1.  Primary:   Distance High Contrast logMAR Visual Acuity at 1 Week   [ Time Frame: Baseline & 1 week ]

2.  Secondary:   Slit Lamp Findings ≥ Grade 2   [ Time Frame: 1 week ]

3.  Secondary:   Overall Comfort   [ 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: NCT01309893     History of Changes
Other Study ID Numbers: 687E
Study First Received: March 4, 2011
Results First Received: November 4, 2014
Last Updated: November 20, 2014
Health Authority: United States: Food and Drug Administration