Back to resultsClinical Evaluation of Stenfilcon A Contact Lenses
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
stenfilcon A lens
narafilcon A lens
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
Inclusion Criteria:
A person is eligible for inclusion in the study if he/she:
- Is Japanese
- Has had a self-reported oculo-visual examination in the last two years.
- Is at least 18 years of age and has full legal capacity to volunteer.
- Has read and understood the informed consent letter.
- Is willing and able to follow instructions and maintain the appointment schedule.
- Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
- Currently wears soft contact lenses.
- Has clear corneas and no active ocular disease.
Exclusion Criteria:
A person will be excluded from the study if he/she:
- Has never worn contact lenses before.
- Has any systemic disease affecting ocular health.
- Is using any systemic or topical medications that will affect ocular health.
- Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
- Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
- Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
- Is aphakic.
- Has undergone corneal refractive surgery.
- Is participating in any other type of eye related clinical or research study.
Sites / Locations
- Shioya Eye Clinic
- Kodama Eye Clinic
- Itoi Eye Clinic
- Ueda Eye Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
stenfilcon A lens
narafilcon A lens
Arm Description
MyDay contact lens
1-Day Acuvue TruEye
Outcomes
Primary Outcome Measures
Lens Movement
Movement of lens after blink: (Categories = Tight, Slightly tight, Optimum, Slightly loose, Loose)
Lens Movement
Movement of lens after blink: (Categories = Tight, Slightly tight, Optimum, Slightly loose, Loose)
Horizontal Lens Centration
Centration of lens horizontally: (Grades = Temporal, Slightly temporal, Centered, Slightly Nasal, Nasal)
Horizontal Lens Centration
Centration of lens horizontally: (Grades = Temporal, Slightly temporal, Centered, Slightly Nasal, Nasal)
Vertical Lens Centration
Centration of lens horizontally: (Grades = Superior, Slightly superior, Center, Slightly inferior, Inferior)
Vertical Lens Centration
Centration of lens horizontally: (Grades = Superior, Slightly superior, Centered, Slightly inferior, Inferior)
Corneal Coverage
Does lens cover the cornea: (Yes, No)
Corneal Coverage
Does lens cover the cornea: (Yes, No)
Lens Lag
Movement after looking right and left: (Grades = Move along with cornea, slight delay, delay)
Lens Lag
Movement after looking right and left: (Grades = Move along with cornea, slight delay, delay)
Overall Fitting Performance
Lens fit performance: (Grades: Optimum, Good, Acceptable, Unacceptable)
Overall Fitting Performance
Lens fit performance: (Grades: Optimum, Good, Acceptable, Unacceptable)
Investigator Fit Preference
Lens fit preference: (Grades: Prefer stenfilcon A strongly, Prefer stenfilcon A slightly, Either, Prefer narafilcon A slightly, Prefer narafilcon A strongly)
Investigator Fit Preference
Lens fit preference: (Grades: Prefer stenfilcon A strongly, Prefer stenfilcon A slightly, Either, Prefer narafilcon A slightly, Prefer narafilcon A strongly)
Secondary Outcome Measures
Comfort
Subjective comfort: (on a scale of 0-10, 0 (Uncomfortable) - 10 (Comfortable))
Comfort
Subjective comfort: (on a scale of 0-10, 0 (Uncomfortable) - 10 (Comfortable))
Comfort
Subjective comfort: (on a scale of 0-10, 0 (Uncomfortable) - 10 (Comfortable))
Dryness
Subjective dryness: (on a scale of 0-10, 0 (Dry) - 10 (Not dry))
Dryness
Subjective dryness: (on a scale of 0-10, 0 (Dry) - 10 (Not dry))
Dryness
Subjective dryness: (on a scale of 0-10, 0 (Dry) - 10 (Not dry))
Stinging/Burning
Subjective stinging/burning sensation: (on a scale of 0-10, 0 (Cannot wear) - 10 (No Stinging/Burning))
Stinging/Burning
Subjective stinging/burning sensation: (on a scale of 0-10, 0 (Cannot wear) - 10 (No Stinging/Burning))
Stinging/Burning
Subjective stinging/burning sensation: (on a scale of 0-10, 0 (Cannot wear) - 10 (No Stinging/Burning))
Edge/Lens Awareness
Subjective edge/lens awareness: (on a scale of 0-10, 0 (Cannot wear) - 10 (No edge awareness))
Edge/Lens Awareness
Subjective edge/lens awareness: (on a scale of 0-10, 0 (Cannot wear) - 10 (No edge awareness))
Edge/Lens Awareness
Subjective edge/lens awareness: (on a scale of 0-10, 0 (Cannot wear) - 10 (No edge awareness))
Subjective Lens Preference
Lens preference (stenfilcon A, Either, Neither, narafilcon A)
Subjective Lens Preference
Lens preference (stenfilcon A, Either, Neither, narafilcon A)
Subjective Lens Preference
Lens preference (stenfilcon A, Either, Neither, narafilcon A)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03471832
Brief Title
Clinical Evaluation of Stenfilcon A Contact Lenses
Official Title
Clinical Evaluation of CooperVision MyDay Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
March 3, 2018 (Actual)
Primary Completion Date
April 25, 2018 (Actual)
Study Completion Date
April 25, 2018 (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
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is to evaluate the fitting performance of stenfilcon A contact lens (test) compared to narafilcon A contact lens (control).
Detailed Description
This study is to evaluate the fitting performance of stenfilcon A contact lens (test) compared to narafilcon A contact lens (control) over 3 hour of wear time in a Japanese population.
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
Model Description
This will be a non-dispensing, randomized, contralateral study comparing a test lens against the appropriate control lens.
Masking
Participant
Masking Description
Each subject will be masked as to which lens is worn on each eye.
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
stenfilcon A lens
Arm Type
Experimental
Arm Description
MyDay contact lens
Arm Title
narafilcon A lens
Arm Type
Active Comparator
Arm Description
1-Day Acuvue TruEye
Intervention Type
Device
Intervention Name(s)
stenfilcon A lens
Other Intervention Name(s)
MyDay, test
Intervention Description
contact lens
Intervention Type
Device
Intervention Name(s)
narafilcon A lens
Other Intervention Name(s)
1-day Acuvue TruEye, control
Intervention Description
contact lens
Primary Outcome Measure Information:
Title
Lens Movement
Description
Movement of lens after blink: (Categories = Tight, Slightly tight, Optimum, Slightly loose, Loose)
Time Frame
5 minutes
Title
Lens Movement
Description
Movement of lens after blink: (Categories = Tight, Slightly tight, Optimum, Slightly loose, Loose)
Time Frame
3hrs
Title
Horizontal Lens Centration
Description
Centration of lens horizontally: (Grades = Temporal, Slightly temporal, Centered, Slightly Nasal, Nasal)
Time Frame
5 minutes
Title
Horizontal Lens Centration
Description
Centration of lens horizontally: (Grades = Temporal, Slightly temporal, Centered, Slightly Nasal, Nasal)
Time Frame
3hrs
Title
Vertical Lens Centration
Description
Centration of lens horizontally: (Grades = Superior, Slightly superior, Center, Slightly inferior, Inferior)
Time Frame
5 minutes
Title
Vertical Lens Centration
Description
Centration of lens horizontally: (Grades = Superior, Slightly superior, Centered, Slightly inferior, Inferior)
Time Frame
3hrs
Title
Corneal Coverage
Description
Does lens cover the cornea: (Yes, No)
Time Frame
5 minutes
Title
Corneal Coverage
Description
Does lens cover the cornea: (Yes, No)
Time Frame
3hrs
Title
Lens Lag
Description
Movement after looking right and left: (Grades = Move along with cornea, slight delay, delay)
Time Frame
5 minutes
Title
Lens Lag
Description
Movement after looking right and left: (Grades = Move along with cornea, slight delay, delay)
Time Frame
3hrs
Title
Overall Fitting Performance
Description
Lens fit performance: (Grades: Optimum, Good, Acceptable, Unacceptable)
Time Frame
5 minutes
Title
Overall Fitting Performance
Description
Lens fit performance: (Grades: Optimum, Good, Acceptable, Unacceptable)
Time Frame
3hrs
Title
Investigator Fit Preference
Description
Lens fit preference: (Grades: Prefer stenfilcon A strongly, Prefer stenfilcon A slightly, Either, Prefer narafilcon A slightly, Prefer narafilcon A strongly)
Time Frame
5 minutes
Title
Investigator Fit Preference
Description
Lens fit preference: (Grades: Prefer stenfilcon A strongly, Prefer stenfilcon A slightly, Either, Prefer narafilcon A slightly, Prefer narafilcon A strongly)
Time Frame
3hrs
Secondary Outcome Measure Information:
Title
Comfort
Description
Subjective comfort: (on a scale of 0-10, 0 (Uncomfortable) - 10 (Comfortable))
Time Frame
Baseline
Title
Comfort
Description
Subjective comfort: (on a scale of 0-10, 0 (Uncomfortable) - 10 (Comfortable))
Time Frame
5 Minutes
Title
Comfort
Description
Subjective comfort: (on a scale of 0-10, 0 (Uncomfortable) - 10 (Comfortable))
Time Frame
3 hours
Title
Dryness
Description
Subjective dryness: (on a scale of 0-10, 0 (Dry) - 10 (Not dry))
Time Frame
Baseline
Title
Dryness
Description
Subjective dryness: (on a scale of 0-10, 0 (Dry) - 10 (Not dry))
Time Frame
5 minutes
Title
Dryness
Description
Subjective dryness: (on a scale of 0-10, 0 (Dry) - 10 (Not dry))
Time Frame
3 hours
Title
Stinging/Burning
Description
Subjective stinging/burning sensation: (on a scale of 0-10, 0 (Cannot wear) - 10 (No Stinging/Burning))
Time Frame
Baseline
Title
Stinging/Burning
Description
Subjective stinging/burning sensation: (on a scale of 0-10, 0 (Cannot wear) - 10 (No Stinging/Burning))
Time Frame
5 minutes
Title
Stinging/Burning
Description
Subjective stinging/burning sensation: (on a scale of 0-10, 0 (Cannot wear) - 10 (No Stinging/Burning))
Time Frame
3 hours
Title
Edge/Lens Awareness
Description
Subjective edge/lens awareness: (on a scale of 0-10, 0 (Cannot wear) - 10 (No edge awareness))
Time Frame
Baseline
Title
Edge/Lens Awareness
Description
Subjective edge/lens awareness: (on a scale of 0-10, 0 (Cannot wear) - 10 (No edge awareness))
Time Frame
5 minutes
Title
Edge/Lens Awareness
Description
Subjective edge/lens awareness: (on a scale of 0-10, 0 (Cannot wear) - 10 (No edge awareness))
Time Frame
3 hours
Title
Subjective Lens Preference
Description
Lens preference (stenfilcon A, Either, Neither, narafilcon A)
Time Frame
Baseline
Title
Subjective Lens Preference
Description
Lens preference (stenfilcon A, Either, Neither, narafilcon A)
Time Frame
5 minutes
Title
Subjective Lens Preference
Description
Lens preference (stenfilcon A, Either, Neither, narafilcon A)
Time Frame
3 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A person is eligible for inclusion in the study if he/she:
Is Japanese
Has had a self-reported oculo-visual examination in the last two years.
Is at least 18 years of age and has full legal capacity to volunteer.
Has read and understood the informed consent letter.
Is willing and able to follow instructions and maintain the appointment schedule.
Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
Currently wears soft contact lenses.
Has clear corneas and no active ocular disease.
Exclusion Criteria:
A person will be excluded from the study if he/she:
Has never worn contact lenses before.
Has any systemic disease affecting ocular health.
Is using any systemic or topical medications that will affect ocular health.
Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
Is aphakic.
Has undergone corneal refractive surgery.
Is participating in any other type of eye related clinical or research study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuji Kodama, MD, PhD
Organizational Affiliation
Kodama Eye Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shioya Eye Clinic
City
Fukushima
State/Province
Fukusima
ZIP/Postal Code
960-8034
Country
Japan
Facility Name
Kodama Eye Clinic
City
Terada
State/Province
Kyoto
ZIP/Postal Code
610-0121
Country
Japan
Facility Name
Itoi Eye Clinic
City
Shibuya
State/Province
Tokyo
ZIP/Postal Code
15-0043
Country
Japan
Facility Name
Ueda Eye Clinic
City
Shimonoseki
State/Province
Yamaguchi
ZIP/Postal Code
751-0872
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Evaluation of Stenfilcon A Contact Lenses
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