Back to resultsDaily Disposable Toric Comparative Trial in Europe
Primary Purpose
Myopia, Astigmatism
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
nelfilcon A contact lens
ocufilcon D contact lens
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
Inclusion Criteria:
- Current soft contact lens wearers able to be fit with soft toric lenses in the protocol-specified parameters.
- Achieve 0.5 or better distance visual acuity in each eye at time of dispense.
- Achieve acceptable or optimal fit in each eye at time of dispense.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Habitual daily disposable contact lens wearer.
- Sleeps in contact lenses overnight.
- Currently enrolled in an ophthalmic clinical trial.
- Other protocol-defined exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
nelfilcon A / ocufilcon D
ocufilcon D / nelfilcon A
Arm Description
Nelfilcon A contact lenses worn first, with ocufilcon D contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
Ocufilcon D contact lenses worn first, with nelfilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
Outcomes
Primary Outcome Measures
Overall Comfort
Overall Comfort, as interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 1-week's wear time. Overall comfort is measured on a 10-point scale, with 1 being poor and 10 being excellent.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01070381
Brief Title
Daily Disposable Toric Comparative Trial in Europe
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CIBA VISION
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to investigate the subjective and objective performance of two daily disposable lenses for wearers with astigmatism.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Astigmatism
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Actual)
8. Arms, Groups, and Interventions
Arm Title
nelfilcon A / ocufilcon D
Arm Type
Other
Arm Description
Nelfilcon A contact lenses worn first, with ocufilcon D contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
Arm Title
ocufilcon D / nelfilcon A
Arm Type
Other
Arm Description
Ocufilcon D contact lenses worn first, with nelfilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
Intervention Type
Device
Intervention Name(s)
nelfilcon A contact lens
Intervention Description
Commercially marketed, toric, soft contact lens for daily disposable wear
Intervention Type
Device
Intervention Name(s)
ocufilcon D contact lens
Intervention Description
Commercially marketed, toric, soft contact lens for daily disposable wear
Primary Outcome Measure Information:
Title
Overall Comfort
Description
Overall Comfort, as interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 1-week's wear time. Overall comfort is measured on a 10-point scale, with 1 being poor and 10 being excellent.
Time Frame
1 week of wear
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Current soft contact lens wearers able to be fit with soft toric lenses in the protocol-specified parameters.
Achieve 0.5 or better distance visual acuity in each eye at time of dispense.
Achieve acceptable or optimal fit in each eye at time of dispense.
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Habitual daily disposable contact lens wearer.
Sleeps in contact lenses overnight.
Currently enrolled in an ophthalmic clinical trial.
Other protocol-defined exclusion criteria may apply.
12. IPD Sharing Statement
Learn more about this trial
Daily Disposable Toric Comparative Trial in Europe
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