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Comparison of Lens Care Regimens With a Silicone Hydrogel Lens (Emerald)

This study has been completed.
Sponsor:
Collaborator:
Alcon Research
Information provided by:
University of Waterloo
ClinicalTrials.gov Identifier:
NCT00520351
First received: August 21, 2007
Last updated: August 20, 2010
Last verified: August 2010
History of Changes
Results First Received: March 26, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Myopia
Interventions: Drug: ClearCare
Drug: Optifree Replenish

  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
Study completion date is August 2008

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Washout for 2 to 3 days following screening (wear spectacles only).

Reporting Groups
  Description
ClearCare First, Then Optifree Replenish In Period 1, participants used ClearCare contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use OptifreeReplenish solution. In the first intervention participants were randomly assigned to use ClearCare first.
Optifree Replenish First, Then ClearCare In Period 1, participants used Optifree Replenish contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use ClearCare solution. In the first intervention, participants were randomly assigned to use Optifree Replenish first.

Participant Flow for 2 periods

 Period 1:   First Intervention
    ClearCare First, Then Optifree Replenish     Optifree Replenish First, Then ClearCare  
STARTED     15 [1]   15 [1]
COMPLETED     14 [2]   14 [2]
NOT COMPLETED     1     1  
Withdrawal by Subject                 1                 1  
[1] Start date is Sep.06, 2007
[2] End date is Feb.25, 2008

Period 2:   Second Intervention
    ClearCare First, Then Optifree Replenish     Optifree Replenish First, Then ClearCare  
STARTED     14     14  
COMPLETED     14     14  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
ClearCare First, Then Optifree Replenish In Period 1, participants used ClearCare contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use OptifreeReplenish solution. In the first intervention participants were randomly assigned to use ClearCare first.
Optifree Replenish First, Then ClearCare In Period 1, participants used Optifree Replenish contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use ClearCare solution. In the first intervention, participants were randomly assigned to use Optifree Replenish first.
Total Total of all reporting groups

Baseline Measures
    ClearCare First, Then Optifree Replenish     Optifree Replenish First, Then ClearCare     Total  
Number of Participants  
[units: participants]
 		  15     15     30  
Age  
[units: participants]
 		     
<=18 years     0     1     1  
Between 18 and 65 years     15     14     29  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  24.4  ± 5.9     24.1  ± 4.4     24.3  ± 5.1  
Gender  
[units: participants]
 		     
Female     13     10     23  
Male     2     5     7  
Region of Enrollment  
[units: participants]
 		     
Canada     15     15     30  



  Outcome Measures
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1.  Primary:   High Contrast Visual Acuity   [ Time Frame: 2 weeks ]
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2.  Primary:   Low Contrast Visual Acuity   [ Time Frame: 2 weeks ]
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Measure Type Primary
Measure Title Low Contrast Visual Acuity
Measure Description

Low Contrast Visual Acuity with contact lenses, was measured using standardized and computer generated logMAR chart.

10 Sloan letters adopted. VA chart's target size varied from logMAR 1.0 to -0.40 in 0.1 logMAR step.
Time Frame 2 weeks  
Safety Issue No  

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.
Analysis was per protocol

Reporting Groups
  Description
ClearCare First, Then Optifree Replenish In Period 1, participants used ClearCare contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use OptifreeReplenish solution. In the first intervention participants were randomly assigned to use ClearCare first.
Optifree Replenish First, Then ClearCare In Period 1, participants used Optifree Replenish contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use ClearCare solution. In the first intervention, participants were randomly assigned to use Optifree Replenish first.

Measured Values
    ClearCare First, Then Optifree Replenish     Optifree Replenish First, Then ClearCare  
Number of Participants Analyzed  
[units: participants]
 		  28     28  
Low Contrast Visual Acuity  
[units: logMAR]
Mean ± Standard Deviation 		  0.26  ± 0.07     0.25  ± 0.08  

No statistical analysis provided for Low Contrast Visual Acuity



3.  Primary:   In-vivo Wettability   [ Time Frame: 2 weeks ]
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4.  Primary:   Subjective Comfort Rating   [ Time Frame: 2 weeks ]
  Show Outcome Measure 4


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


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: Craig A Woods, Research Manager
Organization: Centre for Contact Lens Research
phone: 519-888-4567 ext 36547
e-mail: cawoods@sciborg.uwaterloo.ca


No publications provided


Responsible Party: Craig Woods, Research Manager, CCLR
ClinicalTrials.gov Identifier: NCT00520351     History of Changes
Other Study ID Numbers: P/265/07/L
Study First Received: August 21, 2007
Results First Received: March 26, 2010
Last Updated: August 20, 2010
Health Authority: Canada: Health Canada