Visual Acuity
Conditions
Brief summary
This will be a split-plot design, randomized, parallel, double-masked feasibility study to evaluate the role of a test lens on contrast sensitivity with and without glare.
Interventions
DEVICETest Lens
ACUVUE OASYS MAX 1-Day with TearStable Technology and OptiBlue Light Filter
DEVICEControl Lens
ACUVUE OASYS 1-Day with HydraLuxe Technology
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Potential subjects must satisfy all of the following criteria to be enrolled in the study: The subject must: 1. Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. 2. Appear able and willing to adhere to the instructions set forth in this clinical protocol. 3. Be between 18 and 65 (inclusive) years of age at the time of screening. 4. By self-report, habitually wear spherical silicone hydrogel soft contact lenses in both eyes in a daily reusable or daily disposable wear modality (i.e. not extended wear modality). Habitual wear is defined as a minimum of 6 hours of wear per day, for a minimum of 5 days per week during the past 30 days. 5. Possess a wearable pair of spectacles that provide correction for distance vision. 6. The spherical equivalent of the subject's vertex corrected distance refraction must be between -1.00 D and -6.00 D (inclusive) in each eye. 7. The magnitude of the cylindrical component of the subject's vertex-corrected distance refraction must be between 0.00 D and 1.00 D (inclusive) in each eye. 8. The best corrected, monocular, distance visual acuity must be 20/25 or better in each eye.
Exclusion criteria
Potential subjects who meet any of the following criteria will be excluded from participating in the study: The subject must not: 1. Be currently pregnant or lactating. 2. Be currently using any ocular medications or have any ocular infection of any type. 3. By self-report, have any ocular or systemic disease, allergies, infection, or use of medication the investigator believes might contraindicate or interfere with contact lens wear, or otherwise compromise study endpoints, including infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus \[HIV\]), autoimmune disease (e.g. rheumatoid arthritis, Sjögren's syndrome), or history of serious mental illness or seizures. See section 9.1 for additional details regarding excluded systemic medications. 4. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months. 5. Be currently wearing monovision or multifocal contact lenses. 6. Be currently wearing lenses in an extended wear modality. 7. Have participated in a contact lens or lens care product clinical trial within 30 days prior to study enrollment. 8. Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an employee (including partner, child, parent, grandparent, grandchild or sibling of the employee or their spouse) of the clinical site. 9. Have clinically significant (grade 3 or higher on the FDA grading scale) slit lamp findings (e.g., corneal edema, neovascularization or staining, tarsal abnormalities or bulbar injection) or other corneal or ocular disease or abnormalities that the investigator believes might contraindicate contact lens wear or may otherwise compromise study endpoints (including entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, moderate or above corneal distortion, herpetic keratitis). 10. Have a history of strabismus or amblyopia. 11. Have fluctuations in vision due to clinically significant dry eye or other ocular conditions. 12. Have had any ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, iridotomy, retinal laser photocoagulation, etc.). 13. Have signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar). 14. Have a history of eyelid injury, surgery or procedure that resulted in abnormal eyelid position or movement.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve of Photopic Contrast Sensitivity Function Under Bright Light Conditions (∼120 cd/m2) With a Broadband Glare Source | Up to 2 hours post-fitting | Photopic contrast sensitivity was measured under bright light conditions (\ 120 cd/m2) with a broadband glare source at five spatial frequencies (1.6, 3.2, 8, 16 and 24 cpd) using the University of Georgia system. The area under the log contrast sensitivity function (AULCSF) was derived by first calculating the logarithm of contrast sensitivity as logCS = log10(contrast sensitivity), and then AULCSF was calculated using logCS and the log (base 10) of each spatial frequency based on the trapezoidal rule per eye per subject. The AULCSF was computed by trapezoidal integration of the logarithm of the contrast sensitivity (vertical axis) as a function of the logarithm of spatial frequency (horizontal axis). The unit of the horizontal axis is log(cpd) since spatial frequency is in the unit of cycles per degree (cpd). Although, sensitivity is a unitless parameter, to aid interpretation, the units of AULCSF are described as log(sensitivity)\*log(cpd). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve of Mesopic Contrast Sensitivity Under Dim Light Conditions (∼3 cd/m2) With a Broadband Glare Source. | Up to 2 hours post-fitting | Mesopic contrast sensitivity was measured under dim light conditions (\ 3 cd/m2) with a broadband glare source at five spatial frequencies (1.6, 3.2, 8, 16 and 24 cpd) using the University of Georgia system. The area under the log contrast sensitivity function (AULCSF) was derived by first calculating the logarithm of contrast sensitivity as logCS = log10(contrast sensitivity), and then AULCSF was calculated using logCS and the log (base 10) of each spatial frequency based on the trapezoidal rule per eye per subject. The AULCSF was computed by trapezoidal integration of the logarithm of the contrast sensitivity (vertical axis) as a function of the logarithm of spatial frequency (horizontal axis). The unit of the horizontal axis is log(cpd) since spatial frequency is in the unit of cycles per degree (cpd). Although, sensitivity is a unitless parameter, to aid interpretation, the units of AULCSF are described as log(sensitivity)\*log(cpd). |
Countries
United States
Participant flow
Recruitment details
This was a split-plot design with two parallel arms consisting of two randomized lighting conditions (photopic and mesopic). Within each parallel arm, subjects were further randomized in a contralateral fashion to the Test and Control lenses. A total of 40 subjects were enrolled and completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Photopic Subjects assigned bright light conditions (\
120 cd/m2). | 20 |
| Mesopic Subjects assigned dim light conditions (\
3cd/m2). | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Photopic | Mesopic | Total |
|---|---|---|---|
| Age, Continuous | 37.6 years STANDARD_DEVIATION 14.14 | 37.1 years STANDARD_DEVIATION 13.95 | 37.4 years STANDARD_DEVIATION 13.87 |
| Race/Ethnicity, Customized Asian | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 18 Participants | 16 Participants | 34 Participants |
| Region of Enrollment United States | 20 Participants | 20 Participants | 40 Participants |
| Sex: Female, Male Female | 16 Participants | 18 Participants | 34 Participants |
| Sex: Female, Male Male | 4 Participants | 2 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 40 |
| other Total, other adverse events | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
Primary
Area Under the Curve of Photopic Contrast Sensitivity Function Under Bright Light Conditions (∼120 cd/m2) With a Broadband Glare Source
Photopic contrast sensitivity was measured under bright light conditions (\ 120 cd/m2) with a broadband glare source at five spatial frequencies (1.6, 3.2, 8, 16 and 24 cpd) using the University of Georgia system. The area under the log contrast sensitivity function (AULCSF) was derived by first calculating the logarithm of contrast sensitivity as logCS = log10(contrast sensitivity), and then AULCSF was calculated using logCS and the log (base 10) of each spatial frequency based on the trapezoidal rule per eye per subject. The AULCSF was computed by trapezoidal integration of the logarithm of the contrast sensitivity (vertical axis) as a function of the logarithm of spatial frequency (horizontal axis). The unit of the horizontal axis is log(cpd) since spatial frequency is in the unit of cycles per degree (cpd). Although, sensitivity is a unitless parameter, to aid interpretation, the units of AULCSF are described as log(sensitivity)\*log(cpd).
Time frame: Up to 2 hours post-fitting
Population: All randomized subjects regardless of actual treatment and subsequent withdrawal from study or deviation from protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test (Senofilcon A C3) | Area Under the Curve of Photopic Contrast Sensitivity Function Under Bright Light Conditions (∼120 cd/m2) With a Broadband Glare Source | 1.92 log(sensitivity)*log(cpd) | Standard Deviation 0.22 |
| Control (Senofilcon A C3) | Area Under the Curve of Photopic Contrast Sensitivity Function Under Bright Light Conditions (∼120 cd/m2) With a Broadband Glare Source | 1.62 log(sensitivity)*log(cpd) | Standard Deviation 0.158 |
Secondary
Area Under the Curve of Mesopic Contrast Sensitivity Under Dim Light Conditions (∼3 cd/m2) With a Broadband Glare Source.
Mesopic contrast sensitivity was measured under dim light conditions (\ 3 cd/m2) with a broadband glare source at five spatial frequencies (1.6, 3.2, 8, 16 and 24 cpd) using the University of Georgia system. The area under the log contrast sensitivity function (AULCSF) was derived by first calculating the logarithm of contrast sensitivity as logCS = log10(contrast sensitivity), and then AULCSF was calculated using logCS and the log (base 10) of each spatial frequency based on the trapezoidal rule per eye per subject. The AULCSF was computed by trapezoidal integration of the logarithm of the contrast sensitivity (vertical axis) as a function of the logarithm of spatial frequency (horizontal axis). The unit of the horizontal axis is log(cpd) since spatial frequency is in the unit of cycles per degree (cpd). Although, sensitivity is a unitless parameter, to aid interpretation, the units of AULCSF are described as log(sensitivity)\*log(cpd).
Time frame: Up to 2 hours post-fitting
Population: All randomized subjects regardless of actual treatment and subsequent withdrawal from study or deviation from protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test (Senofilcon A C3) | Area Under the Curve of Mesopic Contrast Sensitivity Under Dim Light Conditions (∼3 cd/m2) With a Broadband Glare Source. | 0.57 log(sensitivity)*log(cpd) | Standard Deviation 0.189 |
| Control (Senofilcon A C3) | Area Under the Curve of Mesopic Contrast Sensitivity Under Dim Light Conditions (∼3 cd/m2) With a Broadband Glare Source. | 0.43 log(sensitivity)*log(cpd) | Standard Deviation 0.14 |