Visual Acuity
Conditions
Brief summary
The study is a bilateral, single-masked, single-visit, non-dispensing 2x2 crossover study to confirm a finalized design of a prototype contact lens. There will be eight study lens types, however, each subject will only be randomized to receive two study lens types.
Interventions
DEVICETest Lens
Multifocal Toric Contact Lenses manufactured in Senofilcon A (C3) material with UV/HEV filter
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 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 at least 40 and not more than 70 years of age at the time of screening. 4. Own a wearable pair of spectacles with distance vision correction. 5. Be an adapted soft contact lens wearer in both eyes (i.e. has worn lenses a minimum of 2 days per week for at least 8 hours per wear day, for the past four weeks). 6. Have distance spherical equivalent refraction in the range of either -1.00 D to -6.00 D or +1.00 to +6.00 D in each eye. 7. Have distance cylinder refraction in the range of -0.75 to - 2.50 D in each eye, with the axis being in the range of either 90 ± 30° or 180 ± 30°. 8. Have best corrected distance visual acuity of 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: 1. Be currently pregnant or lactating. 2. Have any active or ongoing ocular or systemic allergies that may interfere with contact lens wear. 3. Have any active or ongoing systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but not be limited to, diabetes, hyperthyroidism, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens- Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g. hepatitis, tuberculosis). 4. Use systemic medications that may interfere with contact lens wear or cause blurred vision. See section 9.1 for additional details regarding excluded systemic medications. 5. Currently use ocular medication with the exception of rewetting drops. 6. Have any known hypersensitivity or allergic reaction to single use preservative free rewetting drops, or sodium fluorescein. 7. Have had any previous ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, lid procedures, cataract surgery, retinal surgery, etc.). 8. Have a history of amblyopia or strabismus. 9. Have a history of herpetic keratitis. 10. Have a history of irregular cornea. 11. Have a history of pathological dry eye. 12. Have participated in any contact lens or lens care product clinical trial within 14 days prior to study enrollment. 13. Be an employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician). 14. Have clinically significant (Grade 3 or greater) corneal edema, corneal vascularization, corneal staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular abnormalities which would contraindicate contact lens wear. 15. Have entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions. 16. Have any current ocular infection or inflammation. 17. Have any other ocular abnormality that may interfere with contact lens wear
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Eyes With Absolute Rotation ≤ 10 Degrees | 15-minutes post lens insertion | Absolute rotation was assessed for each subject eye using a slit lamp, at 1-, 3-, 7-, 15- and 25-minutes after lens insertion. However, absolute rotation at 15-minutes was the primary endpoint. Acceptable absolute rotation was dichotomized into a binary response where Y=1 if absolute rotation was less than or equal to 10 degrees and Y=0 otherwise (absolute rotation greater than 10 degrees). The proportion of eyes with absolute rotation less than or equal to 10 degrees was report for each lens. |
Countries
United States
Participant flow
Pre-assignment details
A total of 102 subjects were enrolled in this study. Of those enrolled, all subjects were dispensed both lenses and completed the study. No subjects were discontinued.
Baseline characteristics
| Characteristic | Total |
|---|---|
| Age, Continuous | 52.3 years STANDARD_DEVIATION 8.11 |
| Race/Ethnicity, Customized Asian | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 6 Participants |
| Race/Ethnicity, Customized Other | 1 Participants |
| Race/Ethnicity, Customized White | 93 Participants |
| Region of Enrollment United States participants | 102 Participants |
| Sex: Female, Male Female | 81 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 102 | 0 / 102 |
| other Total, other adverse events | 0 / 102 | 0 / 102 |
| serious Total, serious adverse events | 0 / 102 | 0 / 102 |
Outcome results
Primary
Proportion of Eyes With Absolute Rotation ≤ 10 Degrees
Absolute rotation was assessed for each subject eye using a slit lamp, at 1-, 3-, 7-, 15- and 25-minutes after lens insertion. However, absolute rotation at 15-minutes was the primary endpoint. Acceptable absolute rotation was dichotomized into a binary response where Y=1 if absolute rotation was less than or equal to 10 degrees and Y=0 otherwise (absolute rotation greater than 10 degrees). The proportion of eyes with absolute rotation less than or equal to 10 degrees was report for each lens.
Time frame: 15-minutes post lens insertion
Population: All randomized subjects regardless of actual treatment and subsequent withdrawal from study or deviation from protocol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Senofilcon A (C3) Multifocal Toric Lens With UV/HEV Filter (Low DC) | Proportion of Eyes With Absolute Rotation ≤ 10 Degrees | 0.9167 Proportion |
| Senofilcon A (C3) Multifocal Toric Lens With UV/HEV Filter (High DC) | Proportion of Eyes With Absolute Rotation ≤ 10 Degrees | 0.8873 Proportion |
95% CI: [0.878, 0.955]Bootstrapping Methods
95% CI: [0.845, 0.93]Bootstrapping Methods