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Clinical Evaluation of Stenfilcon A Contact Lenses

Clinical Evaluation of CooperVision MyDay Lenses

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03471832
Enrollment
40
Registered
2018-03-21
Start date
2018-03-03
Completion date
2018-04-25
Last updated
2020-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia

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.

Interventions

contact lens

DEVICEnarafilcon A lens

contact lens

Sponsors

CooperVision, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Each subject will be masked as to which lens is worn on each eye.

Intervention model description

This will be a non-dispensing, randomized, contralateral study comparing a test lens against the appropriate control lens.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Investigator Fit Preference5 minutesLens fit preference: (Grades: Prefer stenfilcon A strongly, Prefer stenfilcon A slightly, Either, Prefer narafilcon A slightly, Prefer narafilcon A strongly)
Horizontal Lens Centration5 minutesCentration of lens horizontally: (Grades = Temporal, Slightly temporal, Centered, Slightly Nasal, Nasal)
Vertical Lens Centration5 minutesCentration of lens horizontally: (Grades = Superior, Slightly superior, Center, Slightly inferior, Inferior)
Corneal Coverage5 minutesDoes lens cover the cornea: (Yes, No)
Lens Lag5 minutesMovement after looking right and left: (Grades = Move along with cornea, slight delay, delay)
Overall Fitting Performance5 minutesLens fit performance: (Grades: Optimum, Good, Acceptable, Unacceptable)
Lens Movement5 minutesMovement of lens after blink: (Categories = Tight, Slightly tight, Optimum, Slightly loose, Loose)

Secondary

MeasureTime frameDescription
DrynessBaselineSubjective dryness: (on a scale of 0-10, 0 (Dry) - 10 (Not dry))
Stinging/BurningBaselineSubjective stinging/burning sensation: (on a scale of 0-10, 0 (Cannot wear) - 10 (No Stinging/Burning))
Edge/Lens AwarenessBaselineSubjective edge/lens awareness: (on a scale of 0-10, 0 (Cannot wear) - 10 (No edge awareness))
Subjective Lens PreferenceBaselineLens preference (stenfilcon A, Either, Neither, narafilcon A)
ComfortBaselineSubjective comfort: (on a scale of 0-10, 0 (Uncomfortable) - 10 (Comfortable))

Countries

Japan

Participant flow

Participants by arm

ArmCount
Overall Study
Total Participants
40
Total40

Baseline characteristics

CharacteristicOverall Study
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
40 Participants
Age, Continuous31 years
STANDARD_DEVIATION 10
Race and Ethnicity Not Collected— Participants
Region of Enrollment
Japan
40 participants
Sex: Female, Male
Female
34 Participants
Sex: Female, Male
Male
6 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 400 / 40
other
Total, other adverse events
0 / 400 / 40
serious
Total, serious adverse events
0 / 400 / 40

Outcome results

Primary

Corneal Coverage

Does lens cover the cornea: (Yes, No)

Time frame: 3hrs

ArmMeasureGroupValue (NUMBER)
Stenfilcon A LensCorneal CoverageYes40 number of eyes
Stenfilcon A LensCorneal CoverageNo0 number of eyes
Narafilcon A LensCorneal CoverageYes40 number of eyes
Narafilcon A LensCorneal CoverageNo0 number of eyes
Primary

Corneal Coverage

Does lens cover the cornea: (Yes, No)

Time frame: 5 minutes

ArmMeasureGroupValue (NUMBER)
Stenfilcon A LensCorneal CoverageNo0 number of eyes
Stenfilcon A LensCorneal CoverageYes40 number of eyes
Narafilcon A LensCorneal CoverageYes40 number of eyes
Narafilcon A LensCorneal CoverageNo0 number of eyes
Primary

Horizontal Lens Centration

Centration of lens horizontally: (Grades = Temporal, Slightly temporal, Centered, Slightly Nasal, Nasal)

Time frame: 5 minutes

ArmMeasureGroupValue (NUMBER)
Stenfilcon A LensHorizontal Lens CentrationSlightly temporal4 Number of eyes
Stenfilcon A LensHorizontal Lens CentrationSlightly nasal0 Number of eyes
Stenfilcon A LensHorizontal Lens CentrationCenter36 Number of eyes
Stenfilcon A LensHorizontal Lens CentrationNasal0 Number of eyes
Stenfilcon A LensHorizontal Lens CentrationTemporal0 Number of eyes
Narafilcon A LensHorizontal Lens CentrationNasal0 Number of eyes
Narafilcon A LensHorizontal Lens CentrationTemporal0 Number of eyes
Narafilcon A LensHorizontal Lens CentrationSlightly temporal8 Number of eyes
Narafilcon A LensHorizontal Lens CentrationCenter32 Number of eyes
Narafilcon A LensHorizontal Lens CentrationSlightly nasal0 Number of eyes
Primary

Horizontal Lens Centration

Centration of lens horizontally: (Grades = Temporal, Slightly temporal, Centered, Slightly Nasal, Nasal)

Time frame: 3hrs

ArmMeasureGroupValue (NUMBER)
Stenfilcon A LensHorizontal Lens CentrationSlightly temporal1 number of eyes
Stenfilcon A LensHorizontal Lens CentrationSlightly nasal0 number of eyes
Stenfilcon A LensHorizontal Lens CentrationCenter39 number of eyes
Stenfilcon A LensHorizontal Lens CentrationNasal0 number of eyes
Stenfilcon A LensHorizontal Lens CentrationTemporal0 number of eyes
Narafilcon A LensHorizontal Lens CentrationNasal0 number of eyes
Narafilcon A LensHorizontal Lens CentrationTemporal0 number of eyes
Narafilcon A LensHorizontal Lens CentrationSlightly temporal8 number of eyes
Narafilcon A LensHorizontal Lens CentrationCenter32 number of eyes
Narafilcon A LensHorizontal Lens CentrationSlightly nasal0 number of 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)

Time frame: 3hrs

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Stenfilcon A LensInvestigator Fit PreferencePrefer stenfilcon A strongly5 Participants
Stenfilcon A LensInvestigator Fit PreferencePrefer stenfilcon A slightly12 Participants
Stenfilcon A LensInvestigator Fit PreferenceEither17 Participants
Stenfilcon A LensInvestigator Fit PreferencePrefer narafilcon A slightly6 Participants
Stenfilcon A LensInvestigator Fit PreferencePrefer narafilcon A strongly0 Participants
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)

Time frame: 5 minutes

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Stenfilcon A LensInvestigator Fit PreferencePrefer stenfilcon A strongly5 Participants
Stenfilcon A LensInvestigator Fit PreferencePrefer stenfilcon A slightly6 Participants
Stenfilcon A LensInvestigator Fit PreferenceEither24 Participants
Stenfilcon A LensInvestigator Fit PreferencePrefer narafilcon A slightly4 Participants
Stenfilcon A LensInvestigator Fit PreferencePrefer narafilcon A strongly1 Participants
Primary

Lens Lag

Movement after looking right and left: (Grades = Move along with cornea, slight delay, delay)

Time frame: 5 minutes

ArmMeasureGroupValue (NUMBER)
Stenfilcon A LensLens LagMove along with cornea35 number of eyes
Stenfilcon A LensLens LagSlightly Delay3 number of eyes
Stenfilcon A LensLens LagDelay2 number of eyes
Narafilcon A LensLens LagMove along with cornea34 number of eyes
Narafilcon A LensLens LagSlightly Delay5 number of eyes
Narafilcon A LensLens LagDelay1 number of eyes
Primary

Lens Lag

Movement after looking right and left: (Grades = Move along with cornea, slight delay, delay)

Time frame: 3hrs

ArmMeasureGroupValue (NUMBER)
Stenfilcon A LensLens LagMove along with cornea39 number of eyes
Stenfilcon A LensLens LagSlightly Delay1 number of eyes
Stenfilcon A LensLens LagDelay0 number of eyes
Narafilcon A LensLens LagMove along with cornea36 number of eyes
Narafilcon A LensLens LagSlightly Delay4 number of eyes
Narafilcon A LensLens LagDelay0 number of eyes
Primary

Lens Movement

Movement of lens after blink: (Categories = Tight, Slightly tight, Optimum, Slightly loose, Loose)

Time frame: 3hrs

ArmMeasureGroupValue (NUMBER)
Stenfilcon A LensLens MovementSlightly tight5 Number of eyes
Stenfilcon A LensLens MovementSlightly Loose3 Number of eyes
Stenfilcon A LensLens MovementOptimum32 Number of eyes
Stenfilcon A LensLens MovementLoose0 Number of eyes
Stenfilcon A LensLens MovementTight0 Number of eyes
Narafilcon A LensLens MovementLoose0 Number of eyes
Narafilcon A LensLens MovementTight0 Number of eyes
Narafilcon A LensLens MovementSlightly tight11 Number of eyes
Narafilcon A LensLens MovementOptimum26 Number of eyes
Narafilcon A LensLens MovementSlightly Loose3 Number of eyes
Primary

Lens Movement

Movement of lens after blink: (Categories = Tight, Slightly tight, Optimum, Slightly loose, Loose)

Time frame: 5 minutes

ArmMeasureGroupValue (NUMBER)
Stenfilcon A LensLens MovementTight0 Number of eyes
Stenfilcon A LensLens MovementSlightly tight0 Number of eyes
Stenfilcon A LensLens MovementOptimum30 Number of eyes
Stenfilcon A LensLens MovementSlightly Loose10 Number of eyes
Stenfilcon A LensLens MovementLoose0 Number of eyes
Narafilcon A LensLens MovementLoose0 Number of eyes
Narafilcon A LensLens MovementSlightly Loose7 Number of eyes
Narafilcon A LensLens MovementSlightly tight3 Number of eyes
Narafilcon A LensLens MovementTight0 Number of eyes
Narafilcon A LensLens MovementOptimum30 Number of eyes
Primary

Overall Fitting Performance

Lens fit performance: (Grades: Optimum, Good, Acceptable, Unacceptable)

Time frame: 3hrs

ArmMeasureGroupValue (NUMBER)
Stenfilcon A LensOverall Fitting PerformanceOptimum32 number of eyes
Stenfilcon A LensOverall Fitting PerformanceGood6 number of eyes
Stenfilcon A LensOverall Fitting PerformanceAcceptable2 number of eyes
Stenfilcon A LensOverall Fitting PerformanceUnacceptable0 number of eyes
Narafilcon A LensOverall Fitting PerformanceUnacceptable0 number of eyes
Narafilcon A LensOverall Fitting PerformanceOptimum22 number of eyes
Narafilcon A LensOverall Fitting PerformanceAcceptable4 number of eyes
Narafilcon A LensOverall Fitting PerformanceGood14 number of eyes
Primary

Overall Fitting Performance

Lens fit performance: (Grades: Optimum, Good, Acceptable, Unacceptable)

Time frame: 5 minutes

ArmMeasureGroupValue (NUMBER)
Stenfilcon A LensOverall Fitting PerformanceOptimum30 number of eyes
Stenfilcon A LensOverall Fitting PerformanceGood8 number of eyes
Stenfilcon A LensOverall Fitting PerformanceAcceptable2 number of eyes
Stenfilcon A LensOverall Fitting PerformanceUnacceptable0 number of eyes
Narafilcon A LensOverall Fitting PerformanceUnacceptable0 number of eyes
Narafilcon A LensOverall Fitting PerformanceOptimum25 number of eyes
Narafilcon A LensOverall Fitting PerformanceAcceptable4 number of eyes
Narafilcon A LensOverall Fitting PerformanceGood11 number of eyes
Primary

Vertical Lens Centration

Centration of lens horizontally: (Grades = Superior, Slightly superior, Center, Slightly inferior, Inferior)

Time frame: 5 minutes

ArmMeasureGroupValue (NUMBER)
Stenfilcon A LensVertical Lens CentrationSlightly superior3 Number of eyes
Stenfilcon A LensVertical Lens CentrationSlightly inferior2 Number of eyes
Stenfilcon A LensVertical Lens CentrationCenter35 Number of eyes
Stenfilcon A LensVertical Lens CentrationInferior0 Number of eyes
Stenfilcon A LensVertical Lens CentrationSuperior0 Number of eyes
Narafilcon A LensVertical Lens CentrationInferior0 Number of eyes
Narafilcon A LensVertical Lens CentrationSuperior0 Number of eyes
Narafilcon A LensVertical Lens CentrationSlightly superior10 Number of eyes
Narafilcon A LensVertical Lens CentrationCenter27 Number of eyes
Narafilcon A LensVertical Lens CentrationSlightly inferior3 Number of eyes
Primary

Vertical Lens Centration

Centration of lens horizontally: (Grades = Superior, Slightly superior, Centered, Slightly inferior, Inferior)

Time frame: 3hrs

ArmMeasureGroupValue (NUMBER)
Stenfilcon A LensVertical Lens CentrationSuperior0 Count of eyes
Stenfilcon A LensVertical Lens CentrationSlightly superior1 Count of eyes
Stenfilcon A LensVertical Lens CentrationSlightly inferior0 Count of eyes
Stenfilcon A LensVertical Lens CentrationInferior0 Count of eyes
Stenfilcon A LensVertical Lens CentrationCenter39 Count of eyes
Narafilcon A LensVertical Lens CentrationCenter28 Count of eyes
Narafilcon A LensVertical Lens CentrationSuperior0 Count of eyes
Narafilcon A LensVertical Lens CentrationInferior0 Count of eyes
Narafilcon A LensVertical Lens CentrationSlightly superior6 Count of eyes
Narafilcon A LensVertical Lens CentrationSlightly inferior6 Count of eyes
Secondary

Comfort

Subjective comfort: (on a scale of 0-10, 0 (Uncomfortable) - 10 (Comfortable))

Time frame: 3 hours

ArmMeasureValue (MEAN)Dispersion
Stenfilcon A LensComfort8.2 units on a scaleStandard Deviation 2.3
Narafilcon A LensComfort8.4 units on a scaleStandard Deviation 2.2
Secondary

Comfort

Subjective comfort: (on a scale of 0-10, 0 (Uncomfortable) - 10 (Comfortable))

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Stenfilcon A LensComfort8.1 units on a scaleStandard Deviation 2
Narafilcon A LensComfort8.1 units on a scaleStandard Deviation 1.9
Secondary

Comfort

Subjective comfort: (on a scale of 0-10, 0 (Uncomfortable) - 10 (Comfortable))

Time frame: 5 Minutes

ArmMeasureValue (MEAN)Dispersion
Stenfilcon A LensComfort8.2 units on a scaleStandard Deviation 2.2
Narafilcon A LensComfort8.2 units on a scaleStandard Deviation 1.9
Secondary

Dryness

Subjective dryness: (on a scale of 0-10, 0 (Dry) - 10 (Not dry))

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Stenfilcon A LensDryness9.3 units on a scaleStandard Deviation 1.2
Narafilcon A LensDryness8.1 units on a scaleStandard Deviation 1.9
Secondary

Dryness

Subjective dryness: (on a scale of 0-10, 0 (Dry) - 10 (Not dry))

Time frame: 3 hours

ArmMeasureValue (MEAN)Dispersion
Stenfilcon A LensDryness8.5 units on a scaleStandard Deviation 1.9
Narafilcon A LensDryness8.4 units on a scaleStandard Deviation 2.2
Secondary

Dryness

Subjective dryness: (on a scale of 0-10, 0 (Dry) - 10 (Not dry))

Time frame: 5 minutes

ArmMeasureValue (MEAN)Dispersion
Stenfilcon A LensDryness9.1 units on a scaleStandard Deviation 1.5
Narafilcon A LensDryness8.2 units on a scaleStandard Deviation 1.9
Secondary

Edge/Lens Awareness

Subjective edge/lens awareness: (on a scale of 0-10, 0 (Cannot wear) - 10 (No edge awareness))

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Stenfilcon A LensEdge/Lens Awareness9.0 units on a scaleStandard Deviation 2
Narafilcon A LensEdge/Lens Awareness9.4 units on a scaleStandard Deviation 1.6
Secondary

Edge/Lens Awareness

Subjective edge/lens awareness: (on a scale of 0-10, 0 (Cannot wear) - 10 (No edge awareness))

Time frame: 5 minutes

ArmMeasureValue (MEAN)Dispersion
Stenfilcon A LensEdge/Lens Awareness8.9 units on a scaleStandard Deviation 1.9
Narafilcon A LensEdge/Lens Awareness9.1 units on a scaleStandard Deviation 1.6
Secondary

Edge/Lens Awareness

Subjective edge/lens awareness: (on a scale of 0-10, 0 (Cannot wear) - 10 (No edge awareness))

Time frame: 3 hours

ArmMeasureValue (MEAN)Dispersion
Stenfilcon A LensEdge/Lens Awareness8.7 units on a scaleStandard Deviation 2.4
Narafilcon A LensEdge/Lens Awareness9.2 units on a scaleStandard Deviation 1.8
Secondary

Stinging/Burning

Subjective stinging/burning sensation: (on a scale of 0-10, 0 (Cannot wear) - 10 (No Stinging/Burning))

Time frame: 3 hours

ArmMeasureValue (MEAN)Dispersion
Stenfilcon A LensStinging/Burning9.6 units on a scaleStandard Deviation 1
Narafilcon A LensStinging/Burning9.6 units on a scaleStandard Deviation 0.9
Secondary

Stinging/Burning

Subjective stinging/burning sensation: (on a scale of 0-10, 0 (Cannot wear) - 10 (No Stinging/Burning))

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Stenfilcon A LensStinging/Burning9.5 units on a scaleStandard Deviation 1.2
Narafilcon A LensStinging/Burning8.8 units on a scaleStandard Deviation 2.3
Secondary

Stinging/Burning

Subjective stinging/burning sensation: (on a scale of 0-10, 0 (Cannot wear) - 10 (No Stinging/Burning))

Time frame: 5 minutes

ArmMeasureValue (MEAN)Dispersion
Stenfilcon A LensStinging/Burning9.8 units on a scaleStandard Deviation 0.7
Narafilcon A LensStinging/Burning9.0 units on a scaleStandard Deviation 1.8
Secondary

Subjective Lens Preference

Lens preference (stenfilcon A, Either, Neither, narafilcon A)

Time frame: 3 hours

Population: One subject data was excluded as the subjective lens preference was answered only after 3 hours of lens wear.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Stenfilcon A LensSubjective Lens PreferencePrefer stenfilcon A12 Participants
Stenfilcon A LensSubjective Lens PreferenceEither18 Participants
Stenfilcon A LensSubjective Lens PreferenceNeither1 Participants
Stenfilcon A LensSubjective Lens PreferencePrefer narafilcon A9 Participants
Secondary

Subjective Lens Preference

Lens preference (stenfilcon A, Either, Neither, narafilcon A)

Time frame: 5 minutes

Population: One subject data was excluded as the subjective lens preference was answered only after 3 hours of lens wear.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Stenfilcon A LensSubjective Lens PreferencePrefer stenfilcon A13 Participants
Stenfilcon A LensSubjective Lens PreferenceEither14 Participants
Stenfilcon A LensSubjective Lens PreferenceNeither2 Participants
Stenfilcon A LensSubjective Lens PreferencePrefer narafilcon A10 Participants
Secondary

Subjective Lens Preference

Lens preference (stenfilcon A, Either, Neither, narafilcon A)

Time frame: Baseline

Population: One subject data was excluded as the subjective lens preference was answered only after 3 hours of lens wear.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Stenfilcon A LensSubjective Lens PreferencePrefer stenfilcon A14 Participants
Stenfilcon A LensSubjective Lens PreferenceNeither1 Participants
Stenfilcon A LensSubjective Lens PreferencePrefer narafilcon A11 Participants
Stenfilcon A LensSubjective Lens PreferenceEither13 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026