Evaluation of Disinfecting Solutions and Protein Remover With a Silicone Hydrogel Lens

This study has been completed.
Sponsor:
Collaborator:
Alcon Research
Information provided by:
University of Waterloo
ClinicalTrials.gov Identifier:
NCT00754338
First received: September 17, 2008
Last updated: September 28, 2010
Last verified: September 2010
Results First Received: March 26, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Supportive Care
Condition: Ametropia
Interventions: Drug: Alcon Opti-Free® RepleniSH® with Supraclens®
Drug: Alcon Opti-Free® RepleniSH®
Drug: B&L ReNu MultiPlus™

  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
Recruitment started January 2008 at CCLR (Study completed July 2008)

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Phase 1 - 38 participants enrolled, Phase 2 - 38 participants enrolled. For both Phase 1 and 2 a washout period of at least one day, during which time participants wore spectacles and no contact lenses.

Reporting Groups
  Description
Ph1: 1st-RepleniSH(No-rub) & Supraclens, 2nd RepleniSH(Rub) Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) first, and Alcon RepleniSH™ 'with lens rub' second. Participants wore PureVision lenses on a daily wear basis for at least eight to ten hours per day and at least six days per week for the duration of the study.
Ph1: 1st-RepleniSH(Rub), 2nd-RepleniSH(No-rub) & Supraclens Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' first, and Alcon RepleniSH™ with 'no lens rub' and Supraclens® (Daily protein remover) second. Participants wore PureVision lenses on a daily wear basis for at least eight to ten hours per day and at least six days per week for the duration of the study.
Ph2: 1st-RepleniSH(No-rub)&Supraclens, 2nd ReNUMultiplus(Rub) Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) first, and B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' second. Participants wore PureVision lenses on a daily wear basis for at least eight to ten hours per day and at least six days per week for the duration of the study.
Ph2: 1st-ReNu Multiplus(Rub), 2nd RepleniSH(No-rub)&Supraclens Phase 2 - B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' first, and Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) second. Participants wore PureVision lenses on a daily wear basis for at least eight to ten hours per day and at least six days per week for the duration of the study.

Participant Flow for 2 periods

Period 1:   First Intervention for Phase1&Phase2
    Ph1: 1st-RepleniSH(No-rub) & Supraclens, 2nd RepleniSH(Rub)     Ph1: 1st-RepleniSH(Rub), 2nd-RepleniSH(No-rub) & Supraclens     Ph2: 1st-RepleniSH(No-rub)&Supraclens, 2nd ReNUMultiplus(Rub)     Ph2: 1st-ReNu Multiplus(Rub), 2nd RepleniSH(No-rub)&Supraclens  
STARTED     17     21     19     19  
COMPLETED     17     18     16     19  
NOT COMPLETED     0     3     3     0  
Withdrawal by Subject                 0                 3                 3                 0  

Period 2:   Second Intervention for Phase1&Phase2
    Ph1: 1st-RepleniSH(No-rub) & Supraclens, 2nd RepleniSH(Rub)     Ph1: 1st-RepleniSH(Rub), 2nd-RepleniSH(No-rub) & Supraclens     Ph2: 1st-RepleniSH(No-rub)&Supraclens, 2nd ReNUMultiplus(Rub)     Ph2: 1st-ReNu Multiplus(Rub), 2nd RepleniSH(No-rub)&Supraclens  
STARTED     17     18     16     19  
COMPLETED     17     17     16     18  
NOT COMPLETED     0     1     0     1  
Withdrawal by Subject                 0                 1                 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.
No text entered.

Reporting Groups
  Description
Ph1: RepleniSH(No-rub) & Supraclens Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
Ph1: RepleniSH(Rub) Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
Ph2: RepleniSH(No-rub) & Supraclens Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
Ph2: ReNu Multiplus(Rub) Phase 2 - B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
Total Total of all reporting groups

Baseline Measures
    Ph1: RepleniSH(No-rub) & Supraclens     Ph1: RepleniSH(Rub)     Ph2: RepleniSH(No-rub) & Supraclens     Ph2: ReNu Multiplus(Rub)     Total  
Number of Participants  
[units: participants]
  17     21     19     19     76  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     17     21     19     19     76  
>=65 years     0     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  28  ± 11     21  ± 3     30  ± 9     24  ± 7     26  ± 9  
Gender  
[units: participants]
         
Female     13     17     17     14     61  
Male     4     4     2     5     15  
Region of Enrollment  
[units: participants]
         
Canada     17     21     19     19     76  



  Outcome Measures
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1.  Primary:   Comfort   [ Time Frame: 4 weeks ]

2.  Primary:   Lens Wettability   [ Time Frame: 4 weeks ]

3.  Primary:   Lens Deposits   [ Time Frame: 4 weeks ]

4.  Secondary:   Dryness   [ Time Frame: 4 weeks ]

5.  Secondary:   Subjective Vision   [ Time Frame: 4 weeks ]

6.  Secondary:   Corneal Staining   [ Time Frame: 4 weeks ]


  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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Craig A Woods, Research Manager
Organization: Centre for Contact Lens Research
phone: 1 519 888 4567 ext 36547
e-mail: cawoods@sciborg.uwaterloo.ca


No publications provided


Responsible Party: Desmond Fonn, MOptom., Centre for Contact Lens Research
ClinicalTrials.gov Identifier: NCT00754338     History of Changes
Other Study ID Numbers: P/279/07/L
Study First Received: September 17, 2008
Results First Received: March 26, 2010
Last Updated: September 28, 2010
Health Authority: Canada: Health Canada