Back to resultsClinical Comparison of Two Daily Disposable Toric Lenses
Primary Purpose
Myopia, Astigmatism
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
nelfilcon A contact lens
etafilcon A contact lens
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
Inclusion Criteria:
- Sign written informed consent.
- Germany: Be of legal age.
- Current monthly or weekly toric soft lens wearer able to be fit in both eyes with soft toric lenses in the study parameters.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Eye injury or surgery within twelve weeks.
- Pre-existing ocular irritation that would preclude contact lens fitting.
- Currently enrolled in an ophthalmic clinical trial.
- Wears contact lenses overnight while sleeping.
- Habitual daily disposable contact lens wearer.
- Monovision correction during the study.
- 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 / etafilcon A
etafilcon A / nelfilcon A
Arm Description
Nelfilcon A lenses worn first, with etafilcon A lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
Etafilcon A lenses worn first, with nelfilcon A lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
Outcomes
Primary Outcome Measures
Overall Vision
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision was rated on a 10-point scale, with 1 being poor and 10 being excellent.
Overall Comfort
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall comfort was rated on a 10-point scale, with 1 being poor and 10 being excellent.
Overall Handling
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall handling was rated on a 10-point scale, with 1 being difficult and 10 being easy.
Overall Satisfaction
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision was rated on a 10-point scale, with 1 being poor and 10 being excellent.
Secondary Outcome Measures
Ease of Selecting Final Lens Power
As interpreted by the investigator at time of lens fitting and recorded on a questionnaire. Ease of selecting final lens power was rated on a 10-point scale, with 1 being difficult and 10 being easy.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01362894
Brief Title
Clinical Comparison of Two Daily Disposable Toric Lenses
Official Title
Clinical Comparison of Two Daily Disposable Toric Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 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 was to compare the performance of two contact lenses commercially available for people with astigmatism.
Detailed Description
This trial compared the performance of two commercialized daily disposable contact lenses in Germany.
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
240 (Actual)
8. Arms, Groups, and Interventions
Arm Title
nelfilcon A / etafilcon A
Arm Type
Other
Arm Description
Nelfilcon A lenses worn first, with etafilcon A lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
Arm Title
etafilcon A / nelfilcon A
Arm Type
Other
Arm Description
Etafilcon A lenses worn first, with nelfilcon A 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
Other Intervention Name(s)
Focus® DAILIES® Toric
Intervention Description
Commercially marketed, nelfilcon A, toric, soft contact lens for daily disposable wear.
Intervention Type
Device
Intervention Name(s)
etafilcon A contact lens
Other Intervention Name(s)
1-DAY ACUVUE® MOIST® FOR ASTIGMATISM
Intervention Description
Commercially marketed, etafilcon A, toric, soft contact lens for daily disposable wear.
Primary Outcome Measure Information:
Title
Overall Vision
Description
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision was rated on a 10-point scale, with 1 being poor and 10 being excellent.
Time Frame
1 week, replacing lenses daily
Title
Overall Comfort
Description
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall comfort was rated on a 10-point scale, with 1 being poor and 10 being excellent.
Time Frame
1 week, replacing lenses daily
Title
Overall Handling
Description
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall handling was rated on a 10-point scale, with 1 being difficult and 10 being easy.
Time Frame
1 week, replacing lenses daily
Title
Overall Satisfaction
Description
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision was rated on a 10-point scale, with 1 being poor and 10 being excellent.
Time Frame
1 week, replacing lenses daily
Secondary Outcome Measure Information:
Title
Ease of Selecting Final Lens Power
Description
As interpreted by the investigator at time of lens fitting and recorded on a questionnaire. Ease of selecting final lens power was rated on a 10-point scale, with 1 being difficult and 10 being easy.
Time Frame
Day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Sign written informed consent.
Germany: Be of legal age.
Current monthly or weekly toric soft lens wearer able to be fit in both eyes with soft toric lenses in the study parameters.
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Eye injury or surgery within twelve weeks.
Pre-existing ocular irritation that would preclude contact lens fitting.
Currently enrolled in an ophthalmic clinical trial.
Wears contact lenses overnight while sleeping.
Habitual daily disposable contact lens wearer.
Monovision correction during the study.
Other protocol-defined exclusion criteria may apply.
12. IPD Sharing Statement
Learn more about this trial
Clinical Comparison of Two Daily Disposable Toric Lenses
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