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Feasibility of a New Silicone Hydrogel Lens

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01131130
First received: May 25, 2010
Last updated: March 28, 2014
Last verified: March 2014
Results First Received: March 28, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Single Blind (Subject)
Condition: Myopia
Interventions: Device: Investigational contact lens
Device: Acuvue Oasys Contact Lens
Device: Air Optix Aqua

  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
There were 120 participants enrolled in this bilateral eye, three-period crossover study at four investigative sites in the United States (US). All participants were adapted wearers of soft contact lenses. The first participant was enrolled in the study on 5/10/2010 and the last participant exited the study on 6/10/2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were equally randomized to one of six treatment sequences of the investigational RD2106 contact lens (Test), the Air Optix Aqua contact lens, and the Acuvue Oasys contact lens. Of the 120 participants enrolled 2 were ineligible at baseline and 2 discontinued following dispensing of lenses. 116 participants completed the study.

Reporting Groups
  Description
Over All Study Participants were equally randomized to one of six treatment sequences of the investigational RD2106 contact lens (Test), the Air Optix Aqua contact lens, and the Acuvue Oasys contact lens. Crossover occurred following 1 week of lens wear. The 6 groups were as follows Test, Air Optix Aqua, Acuvue Oasys; Test, Acuvue Oasys, Air Optix Aqua; Air Optix Aqua, Test, Acuvue Oasys; Air Optix Aqua, Acuvue Oasys, Test; Acuvue Oasys, Test, Air Optix Aqua; Acuvue Oasys, Air Optix Aqua, Test.

Participant Flow for 3 periods

Period 1:   Period 1 - Baseline
    Over All Study  
STARTED     118  
COMPLETED     117 [1]
NOT COMPLETED     1  
Pregnancy                 1  
[1] Participant was discontinued 1 day following dispensing and not reported in result tables

Period 2:   Period 2 - Crossover
    Over All Study  
STARTED     117  
COMPLETED     117  
NOT COMPLETED     0  

Period 3:   Period 3- Crossover
    Over All Study  
STARTED     117  
COMPLETED     116  
NOT COMPLETED     1  
+ 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 eligible, dispensed participants

Reporting Groups
  Description
Over All Study Participants were equally randomized to one of six treatment sequences of the investigational RD2106 contact lens (Test), the Air Optix Aqua contact lens, and the Acuvue Oasys contact lens. Crossover occurred following 1 week of lens wear. The 6 groups were as follows Test, Air Optix Aqua, Acuvue Oasys; Test, Acuvue Oasys, Air Optix Aqua; Air Optix Aqua, Test, Acuvue Oasys; Air Optix Aqua, Acuvue Oasys, Test; Acuvue Oasys, Test, Air Optix Aqua; Acuvue Oasys, Air Optix Aqua, Test.

Baseline Measures
    Over All Study  
Number of Participants  
[units: participants]
  117  
Age  
[units: years]
Mean ± Standard Deviation
  31.3  ± 8.5  
Gender  
[units: participants]
 
Female     86  
Male     31  
Region of Enrollment  
[units: participants]
 
United States     117  



  Outcome Measures
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1.  Primary:   Comfort Throughout the Day - Test Lens vs. Air Optix Aqua Lens   [ Time Frame: 7 days ]

2.  Primary:   Comfort Throughout the Day - Test Lens vs. Acuvue Oasys   [ Time Frame: 7 days ]

3.  Secondary:   Lens Wettability, Test Lens vs. Acuvue Oasys   [ Time Frame: 7 days ]

4.  Secondary:   Lens Wettability, Test Lens vs. Air Optix Aqua   [ Time Frame: 7 days ]


  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
No text entered.


  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: NCT01131130     History of Changes
Other Study ID Numbers: 655
Study First Received: May 25, 2010
Results First Received: March 28, 2014
Last Updated: March 28, 2014
Health Authority: United States: Food and Drug Administration