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This study is to evaluate the fitting performance of stenfilcon A contact lens (test) compared to narafilcon A contact lens (control).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| stenfilcon A lens | Experimental | MyDay contact lens |
|
| narafilcon A lens | Active Comparator | 1-Day Acuvue TruEye |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stenfilcon A lens | Device | contact lens |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Lens Movement | Movement of lens after blink: (Categories = Tight, Slightly tight, Optimum, Slightly loose, Loose) | 5 minutes |
| Lens Movement | Movement of lens after blink: (Categories = Tight, Slightly tight, Optimum, Slightly loose, Loose) | 3hrs |
| Horizontal Lens Centration | Centration of lens horizontally: (Grades = Temporal, Slightly temporal, Centered, Slightly Nasal, Nasal) | 5 minutes |
| Horizontal Lens Centration | Centration of lens horizontally: (Grades = Temporal, Slightly temporal, Centered, Slightly Nasal, Nasal) | 3hrs |
| Vertical Lens Centration | Centration of lens horizontally: (Grades = Superior, Slightly superior, Center, Slightly inferior, Inferior) | 5 minutes |
| Vertical Lens Centration | Centration of lens horizontally: (Grades = Superior, Slightly superior, Centered, Slightly inferior, Inferior) | 3hrs |
| Corneal Coverage | Does lens cover the cornea: (Yes, No) | 5 minutes |
| Corneal Coverage | Does lens cover the cornea: (Yes, No) |
| Measure | Description | Time Frame |
|---|---|---|
| Comfort | Subjective comfort: (on a scale of 0-10, 0 (Uncomfortable) - 10 (Comfortable)) | Baseline |
| Comfort | Subjective comfort: (on a scale of 0-10, 0 (Uncomfortable) - 10 (Comfortable)) |
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Inclusion Criteria:
A person is eligible for inclusion in the study if he/she:
Exclusion Criteria:
A person will be excluded from the study if he/she:
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| Name | Affiliation | Role |
|---|---|---|
| Yuji Kodama, MD, PhD | Kodama Eye Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shioya Eye Clinic | Fukushima | Fukushima | 960-8034 | Japan | ||
| Kodama Eye Clinic |
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| ID | Title | Description |
|---|---|---|
| FG000 | Stenfilcon A Lens | Subjects were randomized to wear stenfilcon A lens and narafilcon A lens in this contralateral, non-dispensing study. stenfilcon A lens: contact lens |
| FG001 | Narafilcon A Lens | Subjects were randomized to wear narafilcon A lens and stenfilcon A lens in this contralateral, non-dispensing study. narafilcon A lens: contact lens |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | Total Participants |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Lens Movement | Movement of lens after blink: (Categories = Tight, Slightly tight, Optimum, Slightly loose, Loose) | Posted | Number | Number of eyes | 5 minutes | Eyes | Eyes |
|
From insertion over three hours of lens wear
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stenfilcon A Lens | Subjects were randomized to wear stenfilcon A lens and narafilcon A lens in this contralateral, non-dispensing study. stenfilcon A lens: contact lens |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose A.Vega, O.D., MSc., FAAO | CooperVision | 9256213761 | javega@coopervision.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 26, 2017 | Jul 23, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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This will be a non-dispensing, randomized, contralateral study comparing a test lens against the appropriate control lens.
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Each subject will be masked as to which lens is worn on each eye.
| narafilcon A lens | Device | contact lens |
|
|
| 3hrs |
| Lens Lag | Movement after looking right and left: (Grades = Move along with cornea, slight delay, delay) | 5 minutes |
| Lens Lag | Movement after looking right and left: (Grades = Move along with cornea, slight delay, delay) | 3hrs |
| Overall Fitting Performance | Lens fit performance: (Grades: Optimum, Good, Acceptable, Unacceptable) | 5 minutes |
| Overall Fitting Performance | Lens fit performance: (Grades: Optimum, Good, Acceptable, Unacceptable) | 3hrs |
| Investigator Fit Preference | Lens fit preference: (Grades: Prefer stenfilcon A strongly, Prefer stenfilcon A slightly, Either, Prefer narafilcon A slightly, Prefer narafilcon A strongly) | 5 minutes |
| Investigator Fit Preference | Lens fit preference: (Grades: Prefer stenfilcon A strongly, Prefer stenfilcon A slightly, Either, Prefer narafilcon A slightly, Prefer narafilcon A strongly) | 3hrs |
| 5 Minutes |
| Comfort | Subjective comfort: (on a scale of 0-10, 0 (Uncomfortable) - 10 (Comfortable)) | 3 hours |
| Dryness | Subjective dryness: (on a scale of 0-10, 0 (Dry) - 10 (Not dry)) | Baseline |
| Dryness | Subjective dryness: (on a scale of 0-10, 0 (Dry) - 10 (Not dry)) | 5 minutes |
| Dryness | Subjective dryness: (on a scale of 0-10, 0 (Dry) - 10 (Not dry)) | 3 hours |
| Stinging/Burning | Subjective stinging/burning sensation: (on a scale of 0-10, 0 (Cannot wear) - 10 (No Stinging/Burning)) | Baseline |
| Stinging/Burning | Subjective stinging/burning sensation: (on a scale of 0-10, 0 (Cannot wear) - 10 (No Stinging/Burning)) | 5 minutes |
| Stinging/Burning | Subjective stinging/burning sensation: (on a scale of 0-10, 0 (Cannot wear) - 10 (No Stinging/Burning)) | 3 hours |
| Edge/Lens Awareness | Subjective edge/lens awareness: (on a scale of 0-10, 0 (Cannot wear) - 10 (No edge awareness)) | Baseline |
| Edge/Lens Awareness | Subjective edge/lens awareness: (on a scale of 0-10, 0 (Cannot wear) - 10 (No edge awareness)) | 5 minutes |
| Edge/Lens Awareness | Subjective edge/lens awareness: (on a scale of 0-10, 0 (Cannot wear) - 10 (No edge awareness)) | 3 hours |
| Subjective Lens Preference | Lens preference (stenfilcon A, Either, Neither, narafilcon A) | Baseline |
| Subjective Lens Preference | Lens preference (stenfilcon A, Either, Neither, narafilcon A) | 5 minutes |
| Subjective Lens Preference | Lens preference (stenfilcon A, Either, Neither, narafilcon A) | 3 hours |
| Terada |
| Kyoto |
| 610-0121 |
| Japan |
| Itoi Eye Clinic | Shibuya City | Tokyo | 15-0043 | Japan |
| Ueda Eye Clinic | Shimonoseki | Yamaguchi | 751-0872 | Japan |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| Eyes |
|
|
| Primary | Lens Movement | Movement of lens after blink: (Categories = Tight, Slightly tight, Optimum, Slightly loose, Loose) | Posted | Number | Number of eyes | 3hrs | Eyes | Eyes |
|
|
|
| Primary | Horizontal Lens Centration | Centration of lens horizontally: (Grades = Temporal, Slightly temporal, Centered, Slightly Nasal, Nasal) | Posted | Number | Number of eyes | 5 minutes | Eyes | Eyes |
|
|
|
| Primary | Horizontal Lens Centration | Centration of lens horizontally: (Grades = Temporal, Slightly temporal, Centered, Slightly Nasal, Nasal) | Posted | Number | number of eyes | 3hrs | Eyes | Eyes |
|
|
|
| Primary | Vertical Lens Centration | Centration of lens horizontally: (Grades = Superior, Slightly superior, Center, Slightly inferior, Inferior) | Posted | Number | Number of eyes | 5 minutes | Eyes | Eyes |
|
|
|
| Primary | Vertical Lens Centration | Centration of lens horizontally: (Grades = Superior, Slightly superior, Centered, Slightly inferior, Inferior) | Posted | Number | Count of eyes | 3hrs | Eyes | Eyes |
|
|
|
| Primary | Corneal Coverage | Does lens cover the cornea: (Yes, No) | Posted | Number | number of eyes | 5 minutes | Eyes | Eyes |
|
|
|
| Primary | Corneal Coverage | Does lens cover the cornea: (Yes, No) | Posted | Number | number of eyes | 3hrs | Eyes | Eyes |
|
|
|
| Primary | Lens Lag | Movement after looking right and left: (Grades = Move along with cornea, slight delay, delay) | Posted | Number | number of eyes | 5 minutes | Eyes | Eyes |
|
|
|
| Primary | Lens Lag | Movement after looking right and left: (Grades = Move along with cornea, slight delay, delay) | Posted | Number | number of eyes | 3hrs | Eyes | Eyes |
|
|
|
| Primary | Overall Fitting Performance | Lens fit performance: (Grades: Optimum, Good, Acceptable, Unacceptable) | Posted | Number | number of eyes | 5 minutes | Eyes | Eyes |
|
|
|
| Primary | Overall Fitting Performance | Lens fit performance: (Grades: Optimum, Good, Acceptable, Unacceptable) | Posted | Number | number of eyes | 3hrs | Eyes | Eyes |
|
|
|
| Primary | Investigator Fit Preference | Lens fit preference: (Grades: Prefer stenfilcon A strongly, Prefer stenfilcon A slightly, Either, Prefer narafilcon A slightly, Prefer narafilcon A strongly) | Posted | Count of Participants | Participants | 5 minutes |
|
|
|
| Primary | Investigator Fit Preference | Lens fit preference: (Grades: Prefer stenfilcon A strongly, Prefer stenfilcon A slightly, Either, Prefer narafilcon A slightly, Prefer narafilcon A strongly) | Posted | Count of Participants | Participants | 3hrs |
|
|
|
| Secondary | Comfort | Subjective comfort: (on a scale of 0-10, 0 (Uncomfortable) - 10 (Comfortable)) | Posted | Mean | Standard Deviation | units on a scale | Baseline | Eyes | Eyes |
|
|
|
| Secondary | Comfort | Subjective comfort: (on a scale of 0-10, 0 (Uncomfortable) - 10 (Comfortable)) | Posted | Mean | Standard Deviation | units on a scale | 5 Minutes | Eyes | Eyes |
|
|
|
| Secondary | Comfort | Subjective comfort: (on a scale of 0-10, 0 (Uncomfortable) - 10 (Comfortable)) | Posted | Mean | Standard Deviation | units on a scale | 3 hours | Eyes | Eyes |
|
|
|
| Secondary | Dryness | Subjective dryness: (on a scale of 0-10, 0 (Dry) - 10 (Not dry)) | Posted | Mean | Standard Deviation | units on a scale | Baseline | Eyes | Eyes |
|
|
|
| Secondary | Dryness | Subjective dryness: (on a scale of 0-10, 0 (Dry) - 10 (Not dry)) | Posted | Mean | Standard Deviation | units on a scale | 5 minutes | Eyes | Eyes |
|
|
|
| Secondary | Dryness | Subjective dryness: (on a scale of 0-10, 0 (Dry) - 10 (Not dry)) | Posted | Mean | Standard Deviation | units on a scale | 3 hours | Eyes | Eyes |
|
|
|
| Secondary | Stinging/Burning | Subjective stinging/burning sensation: (on a scale of 0-10, 0 (Cannot wear) - 10 (No Stinging/Burning)) | Posted | Mean | Standard Deviation | units on a scale | Baseline | Eyes | Eyes |
|
|
|
| Secondary | Stinging/Burning | Subjective stinging/burning sensation: (on a scale of 0-10, 0 (Cannot wear) - 10 (No Stinging/Burning)) | Posted | Mean | Standard Deviation | units on a scale | 5 minutes | Eyes | Eyes |
|
|
|
| Secondary | Stinging/Burning | Subjective stinging/burning sensation: (on a scale of 0-10, 0 (Cannot wear) - 10 (No Stinging/Burning)) | Posted | Mean | Standard Deviation | units on a scale | 3 hours | Eyes | Eyes |
|
|
|
| Secondary | Edge/Lens Awareness | Subjective edge/lens awareness: (on a scale of 0-10, 0 (Cannot wear) - 10 (No edge awareness)) | Posted | Mean | Standard Deviation | units on a scale | Baseline | Eyes | Eyes |
|
|
|
| Secondary | Edge/Lens Awareness | Subjective edge/lens awareness: (on a scale of 0-10, 0 (Cannot wear) - 10 (No edge awareness)) | Posted | Mean | Standard Deviation | units on a scale | 5 minutes | Eyes | Eyes |
|
|
|
| Secondary | Edge/Lens Awareness | Subjective edge/lens awareness: (on a scale of 0-10, 0 (Cannot wear) - 10 (No edge awareness)) | Posted | Mean | Standard Deviation | units on a scale | 3 hours | Eyes | Eyes |
|
|
|
| Secondary | Subjective Lens Preference | Lens preference (stenfilcon A, Either, Neither, narafilcon A) | One subject data was excluded as the subjective lens preference was answered only after 3 hours of lens wear. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | Subjective Lens Preference | Lens preference (stenfilcon A, Either, Neither, narafilcon A) | One subject data was excluded as the subjective lens preference was answered only after 3 hours of lens wear. | Posted | Count of Participants | Participants | 5 minutes |
|
|
|
| Secondary | Subjective Lens Preference | Lens preference (stenfilcon A, Either, Neither, narafilcon A) | One subject data was excluded as the subjective lens preference was answered only after 3 hours of lens wear. | Posted | Count of Participants | Participants | 3 hours |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Narafilcon A Lens | Subjects were randomized to wear narafilcon A lens and stenfilcon A lens in this contralateral, non-dispensing study. narafilcon A lens: contact lens | 0 | 40 | 0 | 40 | 0 | 40 |
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| Optimum |
|
| Slightly Loose |
|
| Loose |
|
| Center |
|
| Slightly nasal |
|
| Nasal |
|
| Center |
|
| Slightly nasal |
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| Nasal |
|
| Center |
|
| Slightly inferior |
|
| Inferior |
|
| Center |
|
| Slightly inferior |
|
| Inferior |
|
| Delay |
|
| Delay |
|
| Acceptable |
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| Unacceptable |
|
| Acceptable |
|
| Unacceptable |
|
| Measurements |
|---|
|
| Prefer narafilcon A slightly |
|
| Prefer narafilcon A strongly |
|
| Title |
|---|
| Measurements |
|---|
|
| Prefer narafilcon A slightly |
|
| Prefer narafilcon A strongly |
|
| Title |
|---|
| Measurements |
|---|
|
| Prefer narafilcon A |
|
| Title |
|---|
| Measurements |
|---|
|
| Prefer narafilcon A |
|
| Title |
|---|
| Measurements |
|---|
|
| Prefer narafilcon A |
|