Evaluation of Silicone Hydrogel Lens Wettability With Marketed Lens Care Solutions (SILVER)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01252134
First received: December 1, 2010
Last updated: May 8, 2012
Last verified: May 2012
Results First Received: May 8, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Supportive Care
Condition: Contact Lens Wear
Interventions: Device: Biotrue multipurpose solution
Device: Sauflon Synergi multipurpose solution
Device: OTE Elements multipurpose solution
Device: Silicone hydrogel contact lenses (Acuvue Advance)

  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 and enrolled from one Canadian study center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Synergi, Then Biotrue, Then OTE Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
Synergi, Then OTE, Then Biotrue Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
Biotrue, Then OTE, Then Synergi Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
Biotrue, Then Synergi, Then OTE Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
OTE, Then Biotrue, Then Synergi Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
OTE, Then Synergi, Then Biotrue Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.

Participant Flow for 3 periods

Period 1:   Period 1, 8 Hours
    Synergi, Then Biotrue, Then OTE     Synergi, Then OTE, Then Biotrue     Biotrue, Then OTE, Then Synergi     Biotrue, Then Synergi, Then OTE     OTE, Then Biotrue, Then Synergi     OTE, Then Synergi, Then Biotrue  
STARTED     3     4     3     5     3     4  
COMPLETED     3     3     2     5     3     4  
NOT COMPLETED     0     1     1     0     0     0  
Personal Reasons                 0                 1                 1                 0                 0                 0  

Period 2:   Period 2, 8 Hours
    Synergi, Then Biotrue, Then OTE     Synergi, Then OTE, Then Biotrue     Biotrue, Then OTE, Then Synergi     Biotrue, Then Synergi, Then OTE     OTE, Then Biotrue, Then Synergi     OTE, Then Synergi, Then Biotrue  
STARTED     3     3     2     5     3     4  
COMPLETED     3     3     2     5     3     4  
NOT COMPLETED     0     0     0     0     0     0  

Period 3:   Period 3, 8 Hours
    Synergi, Then Biotrue, Then OTE     Synergi, Then OTE, Then Biotrue     Biotrue, Then OTE, Then Synergi     Biotrue, Then Synergi, Then OTE     OTE, Then Biotrue, Then Synergi     OTE, Then Synergi, Then Biotrue  
STARTED     3     3     2     5     3     4  
COMPLETED     3     3     2     5     3     4  
NOT COMPLETED     0     0     0     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 All enrolled participants

Baseline Measures
    Overall  
Number of Participants  
[units: participants]
  22  
Age  
[units: years]
Mean ± Standard Deviation
  24.8  ± 9.5  
Gender  
[units: participants]
 
Female     13  
Male     9  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Ex Vivo Contact Angle   [ Time Frame: 8 hours ]

2.  Secondary:   Subjective Comfort   [ Time Frame: 8 hours ]

3.  Secondary:   Corneal Staining Type   [ Time Frame: 8 hours ]

4.  Secondary:   Corneal Staining Extent   [ Time Frame: 8 hours ]


  Serious Adverse Events


  Other Adverse Events


  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.


Limitations and Caveats
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.  


Results Point of Contact:  
Name/Title: Director of Medical Affairs
Organization: Alcon Research, Ltd.
phone: 888.451.3937
e-mail: medinfo@alconlabs.com


No publications provided


Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01252134     History of Changes
Other Study ID Numbers: RDG10078 / SILVER
Study First Received: December 1, 2010
Results First Received: May 8, 2012
Last Updated: May 8, 2012
Health Authority: Canada: Ethics Review Committee