Visual Acuity
Conditions
Brief summary
The study is a bilateral, single-masked, single-arm, 3-visit dispensing study. There will be one study treatment, with the subject being in the treatment for approximately 12-16 days.
Interventions
DEVICEToric Multifocal etafilcon A with PVP
Investigational
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Although study includes one arm, Participant is masked to the identity of the investigational product.
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. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. 2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. 3. The subject must be at least 40 and not more than 70 years of age at the time of screening. 4. The subject's distance spherical component of their refraction must be in the range of +1.25 D to +3.75 D in each eye. 5. The subject's refractive cylinder must be -1.00 to -1.50 D in each eye. 6. The subject's ADD power must be in the range of +0.75 D to +1.50 D in each eye. 7. Subject's refractive cylinder axis must be within 90°±30° or 180°±30° in each eye. 8. The subject must have best corrected visual acuity of 20/20-3 or better in each eye. 9. Subjects must own a wearable pair of spectacles if required for their distance vision. 10. The subject must already be wearing a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if not respond positively to at least one symptom on the Presbyopic Symptoms Questionnaire.
Exclusion criteria
* Potential subjects who meet any of the following criteria will be excluded from participating in the study: 1. Currently pregnant or lactating. 2. Any active or ongoing ocular or systemic allergies that may interfere with contact lens wear. 3. 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. Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, corneal staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular abnormalities which would contraindicate contact lens wear. 5. Entropion, ectropion, extrusions, chalazia, recurrent styes, dry eye, glaucoma, history of recurrent corneal erosions. 6. Any previous, or planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, lid procedures, cataract surgery, retinal surgery, etc.). 7. A history of amblyopia, strabismus or binocular vision abnormality. 8. Any current ocular infection or inflammation. 9. Any current ocular abnormality that may interfere with contact lens wear. 10. Use of any of the following oral medications within 1 week prior to enrollment: oral retinoid isotretinoin (e.g. Accutane), oral tetracyclines, topical scopolamine, oral antihistamines (e.g., Chlor-Trimeton, and Benadryl), systemic steroids. 11. Use of any ocular medication, with the exception of rewetting drops. 12. History of herpetic keratitis. 13. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment. 14. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician). 15. Any known hypersensitivity or allergic reaction to Eye-Cept® rewetting drop solution.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distance Visual Acuity (logMAR) | 2-Week Follow-up | High Luminance, high contrast distance (4 meters) binocular visual acuity was recorded with the test contact lenses using ETDRS visual acuity charts. The logMAR visual acuity was measured as follows: 0.02 logMAR=1 letter. Where lower logMAR scores represent better vision. A value of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity. |
| Near Visual Acuity (logMAR) | 2-Week Follow-up | High Luminance, high contrast near (40 centimeters) binocular visual acuity was recorded with the test contact lenses using ETDRS visual acuity charts. The logMAR visual acuity was measured as follows:0.02 logMAR=1 letter. Where lower logMAR scores represent better vision. A value of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity. |
Countries
United States
Participant flow
Recruitment details
In total, 30 subjects were enrolled in this study of which, 28 subjects were assigned and dispensed a study lens, while 2 subjects failed to meet all eligibility criteria. Of the total dispensed subjects, 25 completed the study and 3 subjects were discontinued.
Participants by arm
| Arm | Count |
|---|---|
| Toric Multifocal Etafilcon A With PVP All subjects dispensed a study lens. | 28 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lens handling difficuluties | 2 |
| Overall Study | Subject was not dispensed enough lenses | 1 |
Baseline characteristics
| Characteristic | Toric Multifocal Etafilcon A With PVP |
|---|---|
| Age, Continuous | 51.8 Years STANDARD_DEVIATION 4.98 |
| Race/Ethnicity, Customized Black or African American | 3 Participants |
| Race/Ethnicity, Customized Other | 1 Participants |
| Race/Ethnicity, Customized White | 24 Participants |
| Region of Enrollment United States | 28 Participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 28 |
| other Total, other adverse events | 0 / 28 |
| serious Total, serious adverse events | 0 / 28 |
Outcome results
Primary
Distance Visual Acuity (logMAR)
High Luminance, high contrast distance (4 meters) binocular visual acuity was recorded with the test contact lenses using ETDRS visual acuity charts. The logMAR visual acuity was measured as follows: 0.02 logMAR=1 letter. Where lower logMAR scores represent better vision. A value of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity.
Time frame: 2-Week Follow-up
Population: All sub jects that completed all planned study visits without a major protocol deviation impacting a primary endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Toric Multifocal Etafilcon A With PVP | Distance Visual Acuity (logMAR) | -0.13 logMAR | Standard Deviation 0.095 |
Comparison: Statistically superiority will be concluded if the upper confidence limit will be less than 0.10 logMAR.95% CI: [-0.208, -0.054]Linear Mixed Model
Primary
Near Visual Acuity (logMAR)
High Luminance, high contrast near (40 centimeters) binocular visual acuity was recorded with the test contact lenses using ETDRS visual acuity charts. The logMAR visual acuity was measured as follows:0.02 logMAR=1 letter. Where lower logMAR scores represent better vision. A value of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity.
Time frame: 2-Week Follow-up
Population: All subjects that completed all planned study visits without a major protocol deviation impacting a primary endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Toric Multifocal Etafilcon A With PVP | Near Visual Acuity (logMAR) | 0.06 logMAR | Standard Deviation 0.08 |
Comparison: Statistically superiority will be concluded if the upper confidence limit will be less than 0.17 logMAR for near distance logMAR visual acuity.95% CI: [-0.017, 0.137]Linear Mixed Model