Back to resultsComparison of Two Multifocal Contact Lenses Worn on a Daily Disposable Basis
Primary Purpose
Presbyopia, Myopia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nelfilcon A multifocal contact lens, investigational
Nelfilcon A multifocal contact lens, commercial
Sponsored by
About this trial
This is an interventional treatment trial for Presbyopia
Eligibility Criteria
Inclusion Criteria:
- Age 41 to 68 (inclusive).
- Spectacle add between +0.75 and +2.75D (inclusive).
- Habitual spectacle prescription ≤ 1.00DC (cyl).
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Eye injury or surgery within twelve weeks of enrollment.
- Pre-existing ocular irritation that would preclude contact lens fitting.
- Currently enrolled in a clinical trial.
- Prior refractive surgery.
- Other protocol-defined exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Investigational multifocal / Commercial multifocal
Commercial multifocal / Investigational multifocal
Arm Description
Investigational multifocal contact lenses worn first, with commercial multifocal contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 5 days.
Commercial multifocal contact lenses worn first, with investigational multifocal contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 5 days.
Outcomes
Primary Outcome Measures
End of Day Comfort
End of day comfort was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. End of day comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.
End of Day Dryness
End of day dryness was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. End of day dryness was measured on a 10-point scale, with 1 being very dry and 10 being not dry.
Handling at Removal
Handling at removal was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. Handling at removal was measured on a 10-point scale, with 1 being poor/difficult and 10 being excellent/easy.
Overall Vision
Overall vision was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. Overall vision was measured on a 10-point scale, with 1 being poor and 10 being excellent.
Secondary Outcome Measures
Overall Fit
Overall lens fit was assessed by the investigator at study visit using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit was assessed by eye and graded on a 5-point scale, with 2=unacceptably loose, 1= acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01254760
Brief Title
Comparison of Two Multifocal Contact Lenses Worn on a Daily Disposable Basis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 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 trial is to evaluate and compare the clinical performance of two multifocal contact lenses.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia, Myopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
79 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Investigational multifocal / Commercial multifocal
Arm Type
Other
Arm Description
Investigational multifocal contact lenses worn first, with commercial multifocal contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 5 days.
Arm Title
Commercial multifocal / Investigational multifocal
Arm Type
Other
Arm Description
Commercial multifocal contact lenses worn first, with investigational multifocal contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 5 days.
Intervention Type
Device
Intervention Name(s)
Nelfilcon A multifocal contact lens, investigational
Intervention Description
Investigational, soft, multifocal contact lens for daily wear, daily disposable use.
Intervention Type
Device
Intervention Name(s)
Nelfilcon A multifocal contact lens, commercial
Other Intervention Name(s)
Focus® DAILIES® Progressive
Intervention Description
Commercially marketed, soft, multifocal contact lens FDA-approved for daily wear, daily disposable use.
Primary Outcome Measure Information:
Title
End of Day Comfort
Description
End of day comfort was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. End of day comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.
Time Frame
5 days of wear, lenses replaced daily
Title
End of Day Dryness
Description
End of day dryness was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. End of day dryness was measured on a 10-point scale, with 1 being very dry and 10 being not dry.
Time Frame
5 days of wear, lenses replaced daily
Title
Handling at Removal
Description
Handling at removal was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. Handling at removal was measured on a 10-point scale, with 1 being poor/difficult and 10 being excellent/easy.
Time Frame
5 days of wear, lenses replaced daily
Title
Overall Vision
Description
Overall vision was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. Overall vision was measured on a 10-point scale, with 1 being poor and 10 being excellent.
Time Frame
5 days of wear, lenses replaced daily
Secondary Outcome Measure Information:
Title
Overall Fit
Description
Overall lens fit was assessed by the investigator at study visit using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit was assessed by eye and graded on a 5-point scale, with 2=unacceptably loose, 1= acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight
Time Frame
Day 5, lenses replaced daily
10. Eligibility
Sex
All
Minimum Age & Unit of Time
41 Years
Maximum Age & Unit of Time
68 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 41 to 68 (inclusive).
Spectacle add between +0.75 and +2.75D (inclusive).
Habitual spectacle prescription ≤ 1.00DC (cyl).
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Eye injury or surgery within twelve weeks of enrollment.
Pre-existing ocular irritation that would preclude contact lens fitting.
Currently enrolled in a clinical trial.
Prior refractive surgery.
Other protocol-defined exclusion criteria may apply.
12. IPD Sharing Statement
Learn more about this trial
Comparison of Two Multifocal Contact Lenses Worn on a Daily Disposable Basis
We'll reach out to this number within 24 hrs