Effect of Contact Lenses on Tear Osmolarity in a Controlled Low Humidity Chamber

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT01482312
First received: November 28, 2011
Last updated: June 26, 2012
Last verified: June 2012
Results First Received: May 22, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Myopia
Dry Eye
Interventions: Device: lotrafilcon A contact lenses
Device: comfilcon A contact lenses
Other: Glasses

  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
Twenty-nine participants were randomized into one of three treatment sequences. The study took place at one site, which was located in Canada.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were instructed to use glasses as a washout from their habitual contact lens brand for at least seven days prior to initiating the first of three LHE (Low-Humidity Environment) chamber visits. This reporting group consists of all enrolled participants.

Reporting Groups
  Description
Lotrafilcon A / Comfilcon A / Glasses Lotrafilcon A contact lenses worn first, followed by comfilcon A contact lenses, followed by habitual glasses. Each product worn for 90 minutes in a controlled, low-humidity environment (LHE) chamber. Each period separated by a washout of approximately 7 days.
Comfilcon A / Glasses / Lotrafilcon A Comfilcon A contact lenses worn first, followed by glasses, followed by lotrafilcon A contact lenses. Each product worn for 90 minutes in a controlled, low-humidity environment (LHE) chamber. Each period separated by a washout of approximately 7 days.
Glasses / Lotrafilcon A / Comfilcon A Glasses worn first, followed by lotrafilcon A contact lenses, followed by comfilcon A contact lenses. Each product worn for 90 minutes in a controlled, low-humidity environment (LHE) chamber. Each period separated by a washout of approximately 7 days.

Participant Flow for 3 periods

Period 1:   Period 1, 90 Minutes of Wear
    Lotrafilcon A / Comfilcon A / Glasses     Comfilcon A / Glasses / Lotrafilcon A     Glasses / Lotrafilcon A / Comfilcon A  
STARTED     10     9     10  
COMPLETED     9     9     10  
NOT COMPLETED     1     0     0  
Unspecified                 1                 0                 0  

Period 2:   Period 2, 90 Minutes of Wear
    Lotrafilcon A / Comfilcon A / Glasses     Comfilcon A / Glasses / Lotrafilcon A     Glasses / Lotrafilcon A / Comfilcon A  
STARTED     9     9     9 [1]
COMPLETED     8     9     9  
NOT COMPLETED     1     0     0  
Unspecified                 1                 0                 0  
[1] One participant discontinued between Period 1 and Period 2

Period 3:   Period 3, 90 Minutes of Wear
    Lotrafilcon A / Comfilcon A / Glasses     Comfilcon A / Glasses / Lotrafilcon A     Glasses / Lotrafilcon A / Comfilcon A  
STARTED     8     9     9  
COMPLETED     8     9     9  
NOT COMPLETED     0     0     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
Overall This reporting group includes all enrolled participants.

Baseline Measures
    Overall  
Number of Participants  
[units: participants]
  29  
Age  
[units: years]
Mean ± Standard Deviation
  44.3  ± 12.7  
Gender  
[units: participants]
 
Female     21  
Male     8  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Tear Osmolarity   [ Time Frame: 90 minutes ]

2.  Primary:   Ocular Comfort   [ Time Frame: 90 minutes ]


  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: Director of Alcon Clinical
Organization: Alcon Research
phone: 1-800-241-7629


No publications provided


Responsible Party: Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier: NCT01482312     History of Changes
Other Study ID Numbers: P-373-C-900
Study First Received: November 28, 2011
Results First Received: May 22, 2012
Last Updated: June 26, 2012
Health Authority: Canada: Ethics Review Committee