Back to resultsComparison of Clinical Performance and Subjective Preference of Three Contact Lenses
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
etafilcon A
methafilcon A - Interozzo
methafilcon A - CVI (CooperVision)
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
Inclusion Criteria:
- Age of 18 years and above and has full legal capacity as a volunteer Understand the rights as a research subject and willing and able sign a statement of informed consent
- Existing soft contact lens wearers or previous experience of contact lens wear
- Being able to wear the study lenses for at least eight hours a day
- At least 6/9 visual acuity in each eye with the study lenses
- Astigmatism less than 1.50 D (Diopter) in both eyes
- Agreed to follow the protocol and not to participate in other clinical research for the duration of this study
Exclusion Criteria:
- Have an ocular disorder which would normally contraindicate contact lens wear
- Have a systemic disorder or any infectious diseases which would normally contraindicate contact lens wear
- Have previously had any ocular surgery such as corneal refractive surgery
- Have less than 6/9 visual acuity in each eye with the study lenses
- Are currently using any topical medication such as eye drops or ointment
- Have any corneal distortion resulting from previous rigid lens wear or have keratoconus
- Are currently pregnant or lactating
- No previous contact lens wear
Sites / Locations
- School of Optometry & Vision Science, Catholic University of Daegu, Korea (Rep)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
etafilcon A
methafilcon A - Interozzo
methafilcon A - CVI
Arm Description
Outcomes
Primary Outcome Measures
Comfort
Subjective ratings of comfort for each lens pair was assessed. Scale 0-100, 0=causes pain, 100=very comfortable.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03134599
Brief Title
Comparison of Clinical Performance and Subjective Preference of Three Contact Lenses
Official Title
Comparison of Clinical Performance and Subjective Preference Out of Three Cosmetic Contact Lenses (Limbal Ring-enhancing Lenses, LRE Lenses)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
May 23, 2017 (Actual)
Primary Completion Date
June 24, 2017 (Actual)
Study Completion Date
June 24, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coopervision, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the clinical performance and subject's preference out of three LRE (Limbal Ring Enhancing) lens types: etafilcon A (Johnson&Johnson), methafilcon A (Interozzo), and methafilcon A (CooperVision).
Detailed Description
This will be a subject-masked, bilateral, randomized, crossover dispensing study to compare clinical performance and subjective preference out of three lens types. Sixty subjects will be assigned into three groups and each group will wear the test and control lenses as matched pairs for one week in random order. Lenses will be worn on a daily wear, daily disposable schedule.
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
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
etafilcon A
Arm Type
Active Comparator
Arm Title
methafilcon A - Interozzo
Arm Type
Active Comparator
Arm Title
methafilcon A - CVI
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
etafilcon A
Intervention Description
contact lens
Intervention Type
Device
Intervention Name(s)
methafilcon A - Interozzo
Intervention Description
contact lens
Intervention Type
Device
Intervention Name(s)
methafilcon A - CVI (CooperVision)
Intervention Description
contact lens
Primary Outcome Measure Information:
Title
Comfort
Description
Subjective ratings of comfort for each lens pair was assessed. Scale 0-100, 0=causes pain, 100=very comfortable.
Time Frame
1 week per intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age of 18 years and above and has full legal capacity as a volunteer Understand the rights as a research subject and willing and able sign a statement of informed consent
Existing soft contact lens wearers or previous experience of contact lens wear
Being able to wear the study lenses for at least eight hours a day
At least 6/9 visual acuity in each eye with the study lenses
Astigmatism less than 1.50 D (Diopter) in both eyes
Agreed to follow the protocol and not to participate in other clinical research for the duration of this study
Exclusion Criteria:
Have an ocular disorder which would normally contraindicate contact lens wear
Have a systemic disorder or any infectious diseases which would normally contraindicate contact lens wear
Have previously had any ocular surgery such as corneal refractive surgery
Have less than 6/9 visual acuity in each eye with the study lenses
Are currently using any topical medication such as eye drops or ointment
Have any corneal distortion resulting from previous rigid lens wear or have keratoconus
Are currently pregnant or lactating
No previous contact lens wear
Facility Information:
Facility Name
School of Optometry & Vision Science, Catholic University of Daegu, Korea (Rep)
City
Daegu
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Clinical Performance and Subjective Preference of Three Contact Lenses
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