Visual Acuity
Conditions
Brief summary
This is a single-visit prospective study to establish a real world Marketed Contact Lens 'Through Focus Curve' (TFC) measurement by comparing the consistency of vision between myopes and hyperopes. 33 subjects will be enrolled (at least 15 myopes and 15 hyperopes), who are 40 years of age or older, for a 1-visit, 4-hour study for measurements to be taken.
Interventions
DEVICEetafilcon A
Marketed Multifocal Contact Lens
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. * The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. * The subject must be ≥40 years of age. * The subjects' optimal vertexed spherical equivalent distance correction must be between -6.00 Diopters (D) and +4.00 D in each eye. * The subject's refractive cylinder must be ≤ -0.75 D in each eye. * The subject's ADD power must be in the range of +0.75 to +2.50 D in each eye. * The subject must have best corrected visual acuity of 20/25 or better for each eye. * The subject can be either a new contact lens wearer or an existing soft contact lens wearer.
Exclusion criteria
* Currently pregnant or lactating. * Any ocular or systemic allergies that contraindicate contact lens wear. * Any ocular or systemic disease, autoimmune disease, or use of medication that contraindicates contact lens wear. * Any ocular abnormality that may interfere with contact lens wear. * Use of any ocular medication, with the exception of rewetting drops. * Any previous intraocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.) * Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, and conjunctival injection) which may contraindicate contact lens wear. * History of herpetic keratitis. * Any ocular infection or inflammation. * Any corneal distortion or irregular cornea. * History of binocular vision abnormality or strabismus. * Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV). * History of diabetes. * Participant in unrelated research involving test product within 30 days before planned study visit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distance Binocular LogMAR Visual Acuity | 4 Hr. Post Fitting | Distance Binocular LogMAR Visual Acuity was measured at 4m for Low luminance ( 2.5 CD/M\^2 ), Medium luminance ( 50 CD/M\^2 ) and High luminance ( 250 CD/M\^2 ) |
| Near Binocular LogMAR Visual Acuity | 4 Hr. Post Fitting | Near Binocular LogMAR Visual Acuity was measured at 40cm for Low luminance ( 2.5 CD/M\^2 ), Medium luminance ( 50 CD/M\^2 ) and High luminance ( 250 CD/M\^2 ) |
| Intermediate Binocular LogMAR Visual Acuity | 4 Hr. Post Fitting | intermediate Binocular LogMAR Visual Acuity was measured at 67cm for Low luminance ( 2.5 CD/M\^2 ), Medium luminance ( 50 CD/M\^2 ) and High luminance ( 250 CD/M\^2 ) |
Countries
United Kingdom
Participant flow
Pre-assignment details
A total of 30 subjects were enrolled into this study. Subjects were stratified as either Hyperope or Myopes using a 1:1 allocation. All enrolled subjects completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Etafilcon A (Multi-focal) All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power. | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Etafilcon A (Multi-focal) |
|---|---|
| Age, Continuous | 51.7 years STANDARD_DEVIATION 7.37 |
| Race/Ethnicity, Customized American Indian Or Alaska Native | 0 participants |
| Race/Ethnicity, Customized Asian | 2 participants |
| Race/Ethnicity, Customized Black or African American | 16 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 participants |
| Race/Ethnicity, Customized Other | 2 participants |
| Race/Ethnicity, Customized White | 10 participants |
| Region of Enrollment United Kingdom | 30 participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Distance Binocular LogMAR Visual Acuity
Distance Binocular LogMAR Visual Acuity was measured at 4m for Low luminance ( 2.5 CD/M\^2 ), Medium luminance ( 50 CD/M\^2 ) and High luminance ( 250 CD/M\^2 )
Time frame: 4 Hr. Post Fitting
Population: The analysis population includes all subjects that completed the study without a major protocol deviation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etafilcon A (Multi-focal)- Hyperopes | Distance Binocular LogMAR Visual Acuity | Low Luminance; N=16, N=14 | -1.072 -10*LogMAR | Standard Deviation 0.8748 |
| Etafilcon A (Multi-focal)- Hyperopes | Distance Binocular LogMAR Visual Acuity | Medium Luminance; N=16, N=14 | 0.9017 -10*LogMAR | Standard Deviation 0.45 |
| Etafilcon A (Multi-focal)- Hyperopes | Distance Binocular LogMAR Visual Acuity | High Luminance; N=16, N=14 | 1.488 -10*LogMAR | Standard Deviation 0.696 |
| Etafilcon A (Multi-focal)- Myopes | Distance Binocular LogMAR Visual Acuity | Low Luminance; N=16, N=14 | -0.904 -10*LogMAR | Standard Deviation 1.1423 |
| Etafilcon A (Multi-focal)- Myopes | Distance Binocular LogMAR Visual Acuity | Medium Luminance; N=16, N=14 | 0.557 -10*LogMAR | Standard Deviation 0.9465 |
| Etafilcon A (Multi-focal)- Myopes | Distance Binocular LogMAR Visual Acuity | High Luminance; N=16, N=14 | 1.471 -10*LogMAR | Standard Deviation 1.65 |
Primary
Intermediate Binocular LogMAR Visual Acuity
intermediate Binocular LogMAR Visual Acuity was measured at 67cm for Low luminance ( 2.5 CD/M\^2 ), Medium luminance ( 50 CD/M\^2 ) and High luminance ( 250 CD/M\^2 )
Time frame: 4 Hr. Post Fitting
Population: The analysis population includes all subjects that completed the study without a major protocol deviation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etafilcon A (Multi-focal)- Hyperopes | Intermediate Binocular LogMAR Visual Acuity | Low Luminance; N=16, N=14 | -1.544 -10*LogMAR | Standard Deviation 1.0355 |
| Etafilcon A (Multi-focal)- Hyperopes | Intermediate Binocular LogMAR Visual Acuity | Medium Luminance; N=16, N=14 | -0.075 -10*LogMAR | Standard Deviation 0.8367 |
| Etafilcon A (Multi-focal)- Hyperopes | Intermediate Binocular LogMAR Visual Acuity | High Luminance; N=16, N=14 | 1.056 -10*LogMAR | Standard Deviation 0.7616 |
| Etafilcon A (Multi-focal)- Myopes | Intermediate Binocular LogMAR Visual Acuity | Low Luminance; N=16, N=14 | -1.318 -10*LogMAR | Standard Deviation 1.477 |
| Etafilcon A (Multi-focal)- Myopes | Intermediate Binocular LogMAR Visual Acuity | Medium Luminance; N=16, N=14 | 0.043 -10*LogMAR | Standard Deviation 1.141 |
| Etafilcon A (Multi-focal)- Myopes | Intermediate Binocular LogMAR Visual Acuity | High Luminance; N=16, N=14 | 1.157 -10*LogMAR | Standard Deviation 0.7037 |
Primary
Near Binocular LogMAR Visual Acuity
Near Binocular LogMAR Visual Acuity was measured at 40cm for Low luminance ( 2.5 CD/M\^2 ), Medium luminance ( 50 CD/M\^2 ) and High luminance ( 250 CD/M\^2 )
Time frame: 4 Hr. Post Fitting
Population: The analysis population includes all subjects that completed the study without a major protocol deviation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etafilcon A (Multi-focal)- Hyperopes | Near Binocular LogMAR Visual Acuity | High Luminance; N=16, N=14 | 0.828 -10*LogMAR | Standard Deviation 0.991 |
| Etafilcon A (Multi-focal)- Hyperopes | Near Binocular LogMAR Visual Acuity | Low Luminance; N=16, N=14 | -2.278 -10*LogMAR | Standard Deviation 1.6989 |
| Etafilcon A (Multi-focal)- Hyperopes | Near Binocular LogMAR Visual Acuity | Medium Luminance; N=16, N=14 | -0.591 -10*LogMAR | Standard Deviation 1.4003 |
| Etafilcon A (Multi-focal)- Myopes | Near Binocular LogMAR Visual Acuity | Low Luminance; N=16, N=14 | -2.261 -10*LogMAR | Standard Deviation 1.703 |
| Etafilcon A (Multi-focal)- Myopes | Near Binocular LogMAR Visual Acuity | Medium Luminance; N=16, N=14 | -0.650 -10*LogMAR | Standard Deviation 1.5274 |
| Etafilcon A (Multi-focal)- Myopes | Near Binocular LogMAR Visual Acuity | High Luminance; N=16, N=14 | 0.786 -10*LogMAR | Standard Deviation 1.048 |