Back to resultsClinical Evaluation of Two Daily Disposable Lenses in Neophytes
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
nelfilcon A contact lens
narafilcon A contact lens
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
Inclusion Criteria:
- No previous contact lens experience or attempts to try contact lenses (neophytes).
- Currently wearing spectacles or needing vision correction in both eyes.
- No older than 45 years of age.
- Able to achieve visual acuity of at least 20/40 in each eye with study lenses in the available parameters.
- Interested in wearing contact lenses.
- Willing to wear study lenses for at least 8 hours/day, at least 5 days/week.
- Other protocol-defined inclusion/exclusion criteria may apply.
Exclusion Criteria:
- Eye injury or surgery within twelve weeks prior to enrollment.
- Pre-existing ocular irritation that would preclude contact lens fitting.
- Previous corneal or refractive surgery.
- Currently enrolled in any Clinical Trial.
- Other protocol-defined inclusion/exclusion criteria may apply.
Sites / Locations
- The Research Intelligence Group (TRiG)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
nelfilcon A
narafilcon A
Arm Description
Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.
Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.
Outcomes
Primary Outcome Measures
Overall Lens Satisfaction
Overall Lens Satisfaction, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of 1-week's wear time. Overall lens satisfaction was 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
NCT00987623
Brief Title
Clinical Evaluation of Two Daily Disposable Lenses in Neophytes
Official Title
Clinical Evaluation of Two Daily Disposable Lenses in Neophytes
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (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 evaluate the performance of two daily disposable contact lenses in a population of neophytes (new wearers).
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
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
326 (Actual)
8. Arms, Groups, and Interventions
Arm Title
nelfilcon A
Arm Type
Experimental
Arm Description
Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.
Arm Title
narafilcon A
Arm Type
Active Comparator
Arm Description
Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.
Intervention Type
Device
Intervention Name(s)
nelfilcon A contact lens
Intervention Description
Commercially marketed, hydrogel, single-vision contact lens for daily wear, daily disposable use.
Intervention Type
Device
Intervention Name(s)
narafilcon A contact lens
Intervention Description
Commercially marketed, silicone hydrogel, single-vision contact lens for daily wear, daily disposable use.
Primary Outcome Measure Information:
Title
Overall Lens Satisfaction
Description
Overall Lens Satisfaction, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of 1-week's wear time. Overall lens satisfaction was measured on a 10-point scale, with 1 being Poor and 10 being Excellent
Time Frame
1 week
10. Eligibility
Sex
All
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
No previous contact lens experience or attempts to try contact lenses (neophytes).
Currently wearing spectacles or needing vision correction in both eyes.
No older than 45 years of age.
Able to achieve visual acuity of at least 20/40 in each eye with study lenses in the available parameters.
Interested in wearing contact lenses.
Willing to wear study lenses for at least 8 hours/day, at least 5 days/week.
Other protocol-defined inclusion/exclusion criteria may apply.
Exclusion Criteria:
Eye injury or surgery within twelve weeks prior to enrollment.
Pre-existing ocular irritation that would preclude contact lens fitting.
Previous corneal or refractive surgery.
Currently enrolled in any Clinical Trial.
Other protocol-defined inclusion/exclusion criteria may apply.
Facility Information:
Facility Name
The Research Intelligence Group (TRiG)
City
Fort Washington
State/Province
Pennsylvania
ZIP/Postal Code
19034
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Clinical Evaluation of Two Daily Disposable Lenses in Neophytes
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