Back to resultsOne Month Performance Comparison Between Two Commercially Available Silicone Hydrogel Lenses
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lotrafilcon B contact lens (AIR OPTIX® AQUA)
Galyfilcon A contact lens (ACUVUE® ADVANCE® Plus)
Contact lens solution (Clear Care®)
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
Inclusion Criteria:
- Habitual spherical soft contact lens wearer who wears a contact lens brand with a recommended replacement schedule of 2 weeks or greater.
- Have a need for correction in both eyes and be correctable to at least 20/40 distance vision in each eye at the dispense of study lenses.
- Willing and able to wear spherical contact lenses within the available range of powers.
- Wears contact lenses at least 5 days per week and at least 10 hours per day, removing them nightly.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Eye injury or surgery within twelve weeks prior to enrollment.
- Currently enrolled in any clinical trial.
- Any use of medications for which contact lens wear could be contraindicated, as determined by the investigator.
- Astigmatism of 1.00D or more.
- Currently wearing contact lenses in a daily disposable modality.
- Currently wearing AIR OPTIX AQUA or ACUVUE ADVANCE Plus contact lenses.
- Currently sleeping overnight in contact lenses on an occasional or extended wear basis.
- Other protocol-defined exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Lotrafilcon B
Galyfilcon A
Arm Description
Lotrafilcon B commercially marketed contact lens randomly assigned to one eye, with galyfilcon A commercially marketed contact lens in the fellow eye for contralateral wear. Lenses were worn for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks in a daily wear (DW modality).
Galyfilcon A commercially marketed contact lens randomly assigned to one eye, with lotrafilcon B commercially marketed contact lens in the fellow eye for contralateral wear. Lenses were worn for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks in a daily wear (DW modality).
Outcomes
Primary Outcome Measures
Comfort on Insertion
As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort on insertion was graded on a 10-point scale, with 1 being poor and 10 being excellent.
Comfort During the Day
As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort during the day was graded on a 10-point scale, with 1 being poor and 10 being excellent.
Comfort at End of Day
As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort at end of day was graded on a 10-point scale, with 1 being poor and 10 being excellent.
Overall Comfort
As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall comfort was graded on a 10-point scale, with 1 being poor and 10 being excellent.
Daytime Vision
As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Daytime vision was graded on a 10-point scale, with 1 being poor and 10 being excellent.
Low Light Vision
As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Low light vision was graded on a 10-point scale, with 1 being poor and 10 being excellent.
Handling on Insertion
As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Handling on insertion was graded on a 10-point scale, with 1 being difficult and 10 being easy.
Handling at Removal
As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Handling at removal was graded on a 10-point scale, with 1 being difficult and 10 being easy.
Delivers a Healthy, Natural Feeling
As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Delivers a healthy, natural feeling was graded on a 10-point scale, with 1 being poor and 10 being excellent.
Lens Awareness
As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Lens awareness was graded on a 10-point scale, with 1 being very aware and 10 being not aware.
Overall Satisfaction
As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall satisfaction was graded on a 10-point scale, with 1 being poor and 10 being excellent.
Purchase Intent
As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. The participant was asked, "How likely would you be to purchase these lenses?" Purchase intent was graded on a 5-point Likert scale: Definitely would purchase, probably would purchase, may or may not purchase, probably would not purchase, definitely would not purchase. The Top-2-box response (definitely would purchase, probably would purchase) was calculated and reported as a percentage of all responses.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01300741
Brief Title
One Month Performance Comparison Between Two Commercially Available Silicone Hydrogel Lenses
Official Title
One Month Performance Comparison Between 2 Commercially Available Silicone Hydrogel Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CIBA VISION
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare the performance of two commercially marketed contact lenses when worn for up to one month in a daily wear modality.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lotrafilcon B
Arm Type
Experimental
Arm Description
Lotrafilcon B commercially marketed contact lens randomly assigned to one eye, with galyfilcon A commercially marketed contact lens in the fellow eye for contralateral wear. Lenses were worn for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks in a daily wear (DW modality).
Arm Title
Galyfilcon A
Arm Type
Active Comparator
Arm Description
Galyfilcon A commercially marketed contact lens randomly assigned to one eye, with lotrafilcon B commercially marketed contact lens in the fellow eye for contralateral wear. Lenses were worn for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks in a daily wear (DW modality).
Intervention Type
Device
Intervention Name(s)
Lotrafilcon B contact lens (AIR OPTIX® AQUA)
Other Intervention Name(s)
AIR OPTIX® AQUA
Intervention Description
Silicone hydrogel, single vision contact lens worn in one eye in a daily wear modality for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks.
Intervention Type
Device
Intervention Name(s)
Galyfilcon A contact lens (ACUVUE® ADVANCE® Plus)
Other Intervention Name(s)
ACUVUE® ADVANCE® Plus
Intervention Description
Silicone hydrogel, single vision contact lens worn in one eye in a daily wear modality for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks.
Intervention Type
Device
Intervention Name(s)
Contact lens solution (Clear Care®)
Other Intervention Name(s)
Clear Care®
Intervention Description
Hydrogen peroxide-based system used for cleaning, disinfection and overnight storage of the study contact lenses.
Primary Outcome Measure Information:
Title
Comfort on Insertion
Description
As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort on insertion was graded on a 10-point scale, with 1 being poor and 10 being excellent.
Time Frame
4 weeks
Title
Comfort During the Day
Description
As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort during the day was graded on a 10-point scale, with 1 being poor and 10 being excellent.
Time Frame
4 weeks
Title
Comfort at End of Day
Description
As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort at end of day was graded on a 10-point scale, with 1 being poor and 10 being excellent.
Time Frame
4 weeks
Title
Overall Comfort
Description
As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall comfort was graded on a 10-point scale, with 1 being poor and 10 being excellent.
Time Frame
4 weeks
Title
Daytime Vision
Description
As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Daytime vision was graded on a 10-point scale, with 1 being poor and 10 being excellent.
Time Frame
4 weeks
Title
Low Light Vision
Description
As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Low light vision was graded on a 10-point scale, with 1 being poor and 10 being excellent.
Time Frame
4 weeks
Title
Handling on Insertion
Description
As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Handling on insertion was graded on a 10-point scale, with 1 being difficult and 10 being easy.
Time Frame
4 weeks
Title
Handling at Removal
Description
As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Handling at removal was graded on a 10-point scale, with 1 being difficult and 10 being easy.
Time Frame
4 weeks
Title
Delivers a Healthy, Natural Feeling
Description
As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Delivers a healthy, natural feeling was graded on a 10-point scale, with 1 being poor and 10 being excellent.
Time Frame
4 weeks
Title
Lens Awareness
Description
As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Lens awareness was graded on a 10-point scale, with 1 being very aware and 10 being not aware.
Time Frame
4 weeks
Title
Overall Satisfaction
Description
As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall satisfaction was graded on a 10-point scale, with 1 being poor and 10 being excellent.
Time Frame
4 weeks
Title
Purchase Intent
Description
As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. The participant was asked, "How likely would you be to purchase these lenses?" Purchase intent was graded on a 5-point Likert scale: Definitely would purchase, probably would purchase, may or may not purchase, probably would not purchase, definitely would not purchase. The Top-2-box response (definitely would purchase, probably would purchase) was calculated and reported as a percentage of all responses.
Time Frame
4 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Habitual spherical soft contact lens wearer who wears a contact lens brand with a recommended replacement schedule of 2 weeks or greater.
Have a need for correction in both eyes and be correctable to at least 20/40 distance vision in each eye at the dispense of study lenses.
Willing and able to wear spherical contact lenses within the available range of powers.
Wears contact lenses at least 5 days per week and at least 10 hours per day, removing them nightly.
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Eye injury or surgery within twelve weeks prior to enrollment.
Currently enrolled in any clinical trial.
Any use of medications for which contact lens wear could be contraindicated, as determined by the investigator.
Astigmatism of 1.00D or more.
Currently wearing contact lenses in a daily disposable modality.
Currently wearing AIR OPTIX AQUA or ACUVUE ADVANCE Plus contact lenses.
Currently sleeping overnight in contact lenses on an occasional or extended wear basis.
Other protocol-defined exclusion criteria may apply.
12. IPD Sharing Statement
Learn more about this trial
One Month Performance Comparison Between Two Commercially Available Silicone Hydrogel Lenses
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