Visual Acuity
Conditions
Brief summary
This will be a single site, 2-visit, randomized, controlled, single-masked, non-dispensing, bilateral wear, 2x2 cross over study to assess visual acuity.
Interventions
DEVICEACUVUE OASYS 1-Day for Astigmatism (AO1DfA)
Test Lens
DEVICEDailies Total 1 for Astigmatism (DT1fA)
Control Lens
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 all of 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 years of age (inclusive) at the time of screening. 4. Habitually wear soft, toric contact lenses in both eyes in a daily or daily disposable wear modality (i.e. not extended wear modality). Habitual wearer is defined as a minimum of 6 hours per day, for a minimum of 2 days per week during the past 30 days. 5. Possess a wearable pair of spectacles that provide correction for distance vision (if applicable). 6. Have the spherical component of their vertex-corrected distance refraction within the range +4.00 to -6.00 DS (inclusive) in both eyes. 7. Have the magnitude of the cylindrical component of their vertex-corrected distance refraction between 0.75 DC and 2.50 DC in both eyes. 8. Have best corrected monocular distance visual acuity of 0.2 or better in each eye.
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. Be currently wearing or have had worn Acuvue® Oasys 1-Day for Astigmatism, or Dailies® Total1 for Astigmatism lenses during the last 3 months. 9. Have a history of strabismus or amblyopia. 10. 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. 11. Have participated in a contact lens or lens care product clinical trial within 7 days prior to study enrollment. 12. Have clinically significant (grade 3 or higher on the Efron 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). 13. Have fluctuations in vision due to clinically significant dry eye or other ocular conditions. 14. 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 |
|---|---|---|
| Distance Monocular Visual Acuity (LogMAR) | Approximately 15-minutes Post Lens Insertion | Distance visual acuity was measured monocularly at 6 meters after lens fitting under high-luminance high contrast (HLHC) lighting conditions using the Eurolens computerized logMAR VA chart. Lower scores indicate better visual acuity. A value of 0.0 logMAR is equivalent to 20/20 vision on a Snellen visual acuity chart. |
Countries
United Kingdom
Contacts
STUDY_DIRECTORJohnson & Johnson Vision Care, Inc. Clinical Trial
Johnson & Johnson Vision Care, Inc.
Participant flow
Recruitment details
A total of 6 subjects were enrolled at a single clinical site. Of those enrolled, 1 subject failed to meet all eligibility criteria and 5 subjects were dispensed both study lenses and completed the study.
Participants by arm
| Arm | Count |
|---|---|
| All Dispensed Subjects All subjects dispensed a study lens | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | All Dispensed Subjects |
|---|---|
| Age, Continuous | 32.6 Years STANDARD_DEVIATION 5.94 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Region of Enrollment United Kingdom | 5 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 5 |
| other Total, other adverse events | 0 / 5 | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 |
Outcome results
Primary
Distance Monocular Visual Acuity (LogMAR)
Distance visual acuity was measured monocularly at 6 meters after lens fitting under high-luminance high contrast (HLHC) lighting conditions using the Eurolens computerized logMAR VA chart. Lower scores indicate better visual acuity. A value of 0.0 logMAR is equivalent to 20/20 vision on a Snellen visual acuity chart.
Time frame: Approximately 15-minutes Post Lens Insertion
Population: All subjects fitted both study lenses and completed the study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A | Distance Monocular Visual Acuity (LogMAR) | -0.07 logMAR | Standard Deviation 0.084 |
| Delefilcon A | Distance Monocular Visual Acuity (LogMAR) | -0.07 logMAR | Standard Deviation 0.05 |