Visual Acuity
Conditions
Brief summary
The study is a bilateral, single-masked, single-arm, 4-visit dispensing study evaluating the visual performance of the study lenses.
Detailed description
The study is a bilateral, single-masked, single-arm, 4-visit dispensing study evaluating the visual performance of the study lenses.
Interventions
DEVICEBausch + Lomb Ultra® Multifocal for Astigmatism
Study Lens
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Subjects will be unaware of the identity of the investigational product to help reduce potential bias
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 if required for their distance vision. 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 month). 6. Be an existing wearer of a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or respond positively to at least one symptom on the Presbyopic Symptoms Questionnaire. 7. Have distance spherical component of refraction in the range of either -1.25 D to -3.75 D or +1.25 to +3.75 D in each eye. 8. Have refractive cylinder in the range of -0.75 D to -1.75 D in each eye, with their cylinder axis 90°±25°. 9. Have near ADD power requirement in the range of +0.75 D to +2.50 D in each eye. 10. Have best corrected distance visual acuity of 20/20-3 or better in each eye.
Exclusion criteria
* The subject must not: 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, sodium fluorescein, or Biotrue® multipurpose solution. 7. Have any previous, or planned, 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 2 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 current ocular abnormality that may interfere with contact lens wear.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Binocular High Luminance High Contrast logMAR Visual Acuity | 4-Week Follow-up | Binocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance high contrast condition. At distance (4 meters), VA is assessed using ETDRS (Early Treatment Diabetic Retinopathy Study) charts; while near (40 cm) and intermediate (64 cm) assessments were made using reduced Guillon-Poling charts. Letter-by-letter results calculated the visual performance score for each chart read. LogMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20. |
Countries
United States
Participant flow
Recruitment details
A total of 75 subjects were enrolled into this study. Of those enrolled, 72 were dispensed a study lens, while 3 subjects failed to meet all eligibility criteria. Of those dispensed, 62 subjects completed, and 10 subjects discontinued from the study.
Participants by arm
| Arm | Count |
|---|---|
| Samfilcon A Subjects that were dispensed the study lens. | 72 |
| Total | 72 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lens Discomfort | 3 |
| Overall Study | Other Fractured Test Article | 1 |
| Overall Study | Subject Withdrawn by PI | 2 |
| Overall Study | Unsatisfactory Visual Response due to Test Article | 1 |
| Overall Study | Withdrew Consent during Study | 2 |
Baseline characteristics
| Characteristic | Samfilcon A |
|---|---|
| Age, Continuous | 53.4 Years STANDARD_DEVIATION 8.04 |
| Race/Ethnicity, Customized Asian | 3 Participants |
| Race/Ethnicity, Customized Black or African American | 10 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race/Ethnicity, Customized White | 58 Participants |
| Region of Enrollment United States | 72 Participants |
| Sex: Female, Male Female | 47 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 72 |
| other Total, other adverse events | 0 / 72 |
| serious Total, serious adverse events | 0 / 72 |
Outcome results
Primary
Binocular High Luminance High Contrast logMAR Visual Acuity
Binocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance high contrast condition. At distance (4 meters), VA is assessed using ETDRS (Early Treatment Diabetic Retinopathy Study) charts; while near (40 cm) and intermediate (64 cm) assessments were made using reduced Guillon-Poling charts. Letter-by-letter results calculated the visual performance score for each chart read. LogMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.
Time frame: 4-Week Follow-up
Population: All completed subjects.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Samfilcon A | Binocular High Luminance High Contrast logMAR Visual Acuity | Distance (4m) | -0.13 LogMAR | Standard Deviation 0.097 |
| Samfilcon A | Binocular High Luminance High Contrast logMAR Visual Acuity | Intermediate (64cm) | -0.02 LogMAR | Standard Deviation 0.115 |
| Samfilcon A | Binocular High Luminance High Contrast logMAR Visual Acuity | Near (40cm) | 0.09 LogMAR | Standard Deviation 0.139 |
Comparison: Near (40cm)95% CI: [0.04, 0.15]Mixed Models Analysis
Comparison: Distance (4m)95% CI: [-0.17, -0.07]Mixed Models Analysis
Comparison: Intermediate (64cm)95% CI: [-0.06, 0.04]Mixed Models Analysis