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Lens Wear Schedules and End-of-Day Comfort (INVERMERE)

This study has been completed.
Sponsor:
Collaborator:
University of Waterloo
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT01433549
First received: September 12, 2011
Last updated: April 30, 2013
Last verified: April 2013
Results First Received: March 20, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Supportive Care
Condition: Myopia
Interventions: Device: Lotrafilcon B
Device: Senofilcon 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
Participants were recruited from one study center located in Canada.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 44 participants enrolled, 16 were exited from the study prior to randomization (screen failures). Three subjects were randomized/fitted with lenses but discontinued prior to product dispense. This reporting group includes all participants enrolled and dispensed product. A 12-hour lens-free wear period preceded each phase.

Reporting Groups
  Description
Lotrafilcon B / Senofilcon A Lotrafilcon B worn first, with senofilcon A worn second, as randomized. Each product was worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
Senofilcon A / Lotrafilcon B Senofilcon A worn first, with lotrafilcon B worn second, as randomized. Each product was worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).

Participant Flow for 2 periods

Period 1:   Phase 1: First Study Product
    Lotrafilcon B / Senofilcon A     Senofilcon A / Lotrafilcon B  
STARTED     12     13  
COMPLETED     12     13  
NOT COMPLETED     0     0  

Period 2:   Phase 2: Second Study Product
    Lotrafilcon B / Senofilcon A     Senofilcon A / Lotrafilcon B  
STARTED     12     13  
COMPLETED     12     12  
NOT COMPLETED     0     1  
Adverse Event                 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.
This reporting group includes all participants enrolled and dispensed product.

Reporting Groups
  Description
Overall Lotrafilcon B and Senofilcon A worn in cross-over fashion as randomized. Each product was worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).

Baseline Measures
    Overall  
Number of Participants  
[units: participants]
  25  
Age, Customized  
[units: years]
Median ( Full Range )
  25  
  ( 19 to 43 )  
Gender  
[units: participants]
 
Female     15  
Male     10  
Region of Enrollment  
[units: participants]
 
Canada     25  



  Outcome Measures
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1.  Primary:   Mean End-of-Day Comfort   [ Time Frame: Hour 12 ]

2.  Secondary:   Mean Non-Invasive Tear Film Break-Up Time (NITBUT)   [ Time Frame: Hour 12 ]


  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: R. Alan Landers, O.D., M.S., F.A.A.O.
Organization: Alcon Research, Ltd.
phone: 1-888-451-3937
e-mail: alcon.medinfo@alcon.com


No publications provided


Responsible Party: Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier: NCT01433549     History of Changes
Other Study ID Numbers: P-373-C-104
Study First Received: September 12, 2011
Results First Received: March 20, 2013
Last Updated: April 30, 2013
Health Authority: Canada: Ethics Review Committee