Visual Acuity
Conditions
Brief summary
This will be a 5-visit, randomized, partially single-masked, bilateral wear, dispensing, 2-treatment × 2-period crossover study with spectacle-wear washout and wash-in periods.
Interventions
DEVICEACUVUE Oasys 1-Day with HydraLuxe Technology for Astigmatism
TEST
DEVICEACUVUE Oasys 1-Day with HydraLuxe Technology
CONTROL
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
Yes
Inclusion criteria
* Potential subjects must satisfy of all the following criteria to be enrolled in the study. 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 39 (inclusive) years of age at the time of screening. 4. By self-report, habitually wear soft contact lenses (sphere or toric) 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 2 days per week during the past 4 weeks. 5. Possess a wearable pair of spectacles that provide correction for distance vision. 6. In both eyes, have magnitude of the cylinder component of their vertex-corrected distance refraction greater than or equal to 0.625 DC and less than 1.625 DC. 7. In both eyes, have the mean sphere of their vertex-corrected distance refraction minus half of the indicated contact lens label cylinder power be between -0.875 to -4.625 DS (inclusive). 8. For each eye, have the cylinder axis of their distance refraction between 165° and 15° (i.e., 180±15°, inclusive) or between 75° and 105° (i.e., 90±15°, inclusive). 9. For both eyes, have the sphere power of their habitual spectacles within ±0.50 Diopters Sphere (DS) (inclusive) of the sphere power of their current subjective refraction. 10. For both eyes, have the cylinder power of their habitual spectacles within ±0.50 Diopters Cylinder (DC) (inclusive) of the cylinder power of their current subjective refraction. 11. For both eyes, have the cylinder axis of their habitual spectacles within ±20° (inclusive) of the cylinder axis of their current subjective refraction. 12. Achieve monocular VA of 20/30 or better with their habitual spectacles in both eyes.
Exclusion criteria
* Potential subjects who meet any of the following criteria will be excluded from participating in the study: 1. Be currently pregnant or lactating. 2. Be diabetic. 3. Be currently using any ocular medications or have any ocular infection of any type. 4. By self-report, have any ocular or systemic disease, allergies, infection, or use of medication that 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. 5. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months. 6. Be currently wearing monovision or multifocal contact lenses. 7. Be currently wearing lenses in an extended wear modality. 8. Have a history of strabismus or amblyopia. 9. 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. 10. Have participated in a contact lens or lens care product clinical trial within 7 days prior to study enrollment. 11. 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 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). 12. Have fluctuations in vision due to clinically significant dry eye or other ocular conditions. 13. Have had or have planned (within the study period) any ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, iridotomy, retinal laser photocoagulation, etc.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| High Luminance High Contrast Monocular Visual Acuity (LogMAR) | 1-Week Follow-up | Visual Acuity was collected for each subject eye at distance (4 meter) using a Logarithm of Minimal Angle of Resolution (logMAR) visual acuity scale. This was evaluated under high luminance and high contrast conditions (HLHC) at 4 meters from Early Treatment Diabetic Retinopathy Study (ETDRS) charts at the 1-week follow-up visit. A value of 0.0 logMAR is equivalent to 20/20 Snellen Visual Acuity. Lower values of visual acuity indicate better vision. The average logMAR Visual Acuity was reported for each lens type. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CLUE Vision Score | 1-Week Follow-up | CLUE Vision Score was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. The average CLUE vision score for each lens type was reported. |
| High Luminance High Contrast Monocular Visual Acuity (LogMAR) | 1-Week Follow-up | Visual Acuity was collected for each subject eye at distance (4 meter) using a Logarithm of Minimal Angle of Resolution (logMAR) visual acuity scale. This was evaluated under high luminance and high contrast conditions (HLHC) at 4 meters from Early Treatment Diabetic Retinopathy Study (ETDRS) charts at the 1-week follow-up visit. A value of 0.0 logMAR is equivalent to 20/20 Snellen Visual Acuity. Lower values of visual acuity indicate better vision. The average logMAR Visual Acuity was reported for each lens type. Data summaries for the Control lens are reported for the first primary measure outcome. |
| Subjective Contact Lens Preference | 1-Week Follow-up | — |
Countries
United States
Participant flow
Recruitment details
A total of 174 subjects were enrolled in this study. Of those enrolled, a total of 161 subjects were assigned to one of two wear sequences; while 13 subjects were screen failure and/or not assigned. Of the total assigned subjects, 151 subjects completed the study while, 10 subjects were discontinued from the study.
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 | Site COVID-19 Related | 3 | 3 |
| Period 1 | Subject No Longer Meets Eligibility Criteria | 1 | 0 |
| Period 1 | Subject Withdrawn by PI due to Non Compliance to Protocol | 0 | 1 |
| Period 2 | COVID-19 Related | 1 | 0 |
| Period 2 | Subject No Longer Meets Eligibility Criteria | 1 | 0 |
Baseline characteristics
| Characteristic | Total |
|---|---|
| Age, Continuous | 27.9 years STANDARD_DEVIATION 5.43 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 15 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants |
| Race (NIH/OMB) More than one race | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 4 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 122 Participants |
| Region of Enrollment United States | 161 participants |
| Sex: Female, Male Female | 109 Participants |
| Sex: Female, Male Male | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 157 | 0 / 157 |
| other Total, other adverse events | 0 / 157 | 0 / 157 |
| serious Total, serious adverse events | 0 / 157 | 0 / 157 |
Outcome results
Primary
High Luminance High Contrast Monocular Visual Acuity (LogMAR)
Visual Acuity was collected for each subject eye at distance (4 meter) using a Logarithm of Minimal Angle of Resolution (logMAR) visual acuity scale. This was evaluated under high luminance and high contrast conditions (HLHC) at 4 meters from Early Treatment Diabetic Retinopathy Study (ETDRS) charts at the 1-week follow-up visit. A value of 0.0 logMAR is equivalent to 20/20 Snellen Visual Acuity. Lower values of visual acuity indicate better vision. The average logMAR Visual Acuity was reported for each lens type.
Time frame: 1-Week Follow-up
Population: All randomized subjects regardless of actual treatment and subsequent withdrawal from the study or deviation from the protocol. At least one observation was recorded.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test (AO1DfA) | High Luminance High Contrast Monocular Visual Acuity (LogMAR) | -0.126 logMAR | Standard Deviation 0.0798 |
| Control (AO1D) | High Luminance High Contrast Monocular Visual Acuity (LogMAR) | -0.028 logMAR | Standard Deviation 0.1123 |
95% CI: [-0.113, -0.081]Linear Mixed Model
Secondary
CLUE Vision Score
CLUE Vision Score was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. The average CLUE vision score for each lens type was reported.
Time frame: 1-Week Follow-up
Population: All randomized subjects regardless of actual treatment and subsequent withdrawal from the study or deviation from the protocol. At least one observation was recorded.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test (AO1DfA) | CLUE Vision Score | 69.39 units on a scale | Standard Deviation 20.151 |
| Control (AO1D) | CLUE Vision Score | 41.49 units on a scale | Standard Deviation 28.139 |
95% CI: [22.6, 33.3]Linear Mixed Model
Secondary
High Luminance High Contrast Monocular Visual Acuity (LogMAR)
Visual Acuity was collected for each subject eye at distance (4 meter) using a Logarithm of Minimal Angle of Resolution (logMAR) visual acuity scale. This was evaluated under high luminance and high contrast conditions (HLHC) at 4 meters from Early Treatment Diabetic Retinopathy Study (ETDRS) charts at the 1-week follow-up visit. A value of 0.0 logMAR is equivalent to 20/20 Snellen Visual Acuity. Lower values of visual acuity indicate better vision. The average logMAR Visual Acuity was reported for each lens type. Data summaries for the Control lens are reported for the first primary measure outcome.
Time frame: 1-Week Follow-up
Population: All subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test (AO1DfA) | High Luminance High Contrast Monocular Visual Acuity (LogMAR) | -0.128 logMAR | Standard Deviation 0.0799 |
| Control (AO1D) | High Luminance High Contrast Monocular Visual Acuity (LogMAR) | -0.107 logMAR | Standard Deviation 0.0812 |
95% CI: [-0.032, -0.008]Linear Mixed Model
Secondary
Subjective Contact Lens Preference
Time frame: 1-Week Follow-up
Population: All randomized subjects regardless of actual treatment and subsequent withdrawal from the study or deviation from the protocol. At least one observation was recorded.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Test (AO1DfA) | Subjective Contact Lens Preference | Prefer Test | 0.689 proportion of participants |
| Test (AO1DfA) | Subjective Contact Lens Preference | Prefer Control | 0.225 proportion of participants |
| Test (AO1DfA) | Subjective Contact Lens Preference | No Preference | 0.086 proportion of participants |
95% CI: [1.73, 5.11]Generalized Linear Mixed Model