Visual Acuity
Conditions
Brief summary
This is a single-masked, two-arm, parallel-group, randomized-controlled, dispensing clinical trial to evaluate the visual performance.
Interventions
DEVICEsenofilcon A C3
TEST Lens
DEVICEDailies Total 1 Multifocal Contact Lenses
CONTROL Lens
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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 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 years of age and not greater than 70 years of age at the time of consent. 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. worn lenses a minimum of 2 days per week for at least 6 hours per wear day, for 1 month or more duration). 6. Either 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. 7. The subject's distance spherical equivalent refraction must be in the range of -1.25 D to -3.75 D or +1.25 D to +3.75 D in each eye. 8. The subject's refractive cylinder must be ≤0.75 D in each eye. 9. The subject's ADD power must be in the range of +0.75 D to +2.50 D. 10. The subject must have distance best corrected visual acuity of 20/20-3 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. Have any previous, or planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, lid procedures, cataract surgery, retinal surgery, etc.). 5. Have a history of amblyopia, strabismus or binocular vision abnormality. 6. Use of any of the following medications within 1 week prior to enrollment: oral retinoid, oral tetracyclines, anticholinergics, oral phenothiazines, oral/inhaled corticosteroids. See Table 9.1 for further examples. 7. Use of any ocular medication, with the exception of rewetting drops. 8. Have a history of herpetic keratitis. 9. Have a history of irregular cornea. 10. Have a history of pathological dry eye. 11. Have Participated in any contact lens or lens care product clinical trial within 30 days prior to study enrollment. 12. Be and employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician). 13. Have any known hypersensitivity or allergic reaction to non-preserved rewetting drop solutions or sodium fluorescein. 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 any current ocular infection or inflammation. 16. Have any current ocular abnormality that may interfere with contact lens wear.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Binocular logMAR Visual Acuity | 1-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. |
| CLUE Vision Score | 1-Week Follow-up | Subjective vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patientreported 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Binocular Distance logMAR Visual Acuity | 1-Week Follow-up | Binocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale at distance (4m) under high luminance high contrast condition assessed using ETDRS (Early Treatment Diabetic Retinopathy Study) 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 77 subjects were enrolled in this study. Of those enrolled, 74 subjects were dispensed at least one study lens, while 3 subject failed to meet all eligibility criteria. Of those dispensed, 69 subjects completed the study while 5 subjects were discontinued.
Participants by arm
| Arm | Count |
|---|---|
| Test (Senofilcon A C3) Subjects that wore the Test lens during the study. | 36 |
| Control (Delefilcon A) Subjects that wore the Control lens during the study. | 34 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Subject dispensed incorrect lens in 1 eye | 1 | 1 |
| Overall Study | Subject Withdrawn by PI due to Non Compliance to Protocol | 0 | 1 |
| Overall Study | Unsatisfactory Test Article | 1 | 0 |
| Overall Study | Withdrew Consent during study | 0 | 1 |
Baseline characteristics
| Characteristic | Control (Delefilcon A) | Total | Test (Senofilcon A C3) |
|---|---|---|---|
| Age, Continuous | 55.4 Years STANDARD_DEVIATION 5.48 | 56.7 Years STANDARD_DEVIATION 5.84 | 58.0 Years STANDARD_DEVIATION 5.95 |
| Race/Ethnicity, Customized Asian | 1 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 3 Participants | 6 Participants | 3 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 29 Participants | 61 Participants | 32 Participants |
| Region of Enrollment United States | 34 Participants | 70 Participants | 36 Participants |
| Sex: Female, Male Female | 24 Participants | 55 Participants | 31 Participants |
| Sex: Female, Male Male | 10 Participants | 15 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 37 | 0 / 37 |
| other Total, other adverse events | 0 / 37 | 0 / 37 |
| serious Total, serious adverse events | 0 / 37 | 0 / 37 |
Outcome results
Primary
Binocular 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: 1-Week Follow-up
Population: All randomized subjects regardless of actual treatment and subsequent withdrawal from study or deviation from protocol, with data at the 1-Week Follow-up Evaluation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test (Senofilcon A C3) | Binocular logMAR Visual Acuity | Near (40cm) | 0.090 LogMAR | Standard Deviation 0.0924 |
| Test (Senofilcon A C3) | Binocular logMAR Visual Acuity | Distance (4m) | -0.076 LogMAR | Standard Deviation 0.0915 |
| Test (Senofilcon A C3) | Binocular logMAR Visual Acuity | Intermediate (64cm) | 0.006 LogMAR | Standard Deviation 0.0876 |
| Control (Delefilcon A) | Binocular logMAR Visual Acuity | Near (40cm) | 0.084 LogMAR | Standard Deviation 0.0904 |
| Control (Delefilcon A) | Binocular logMAR Visual Acuity | Distance (4m) | -0.081 LogMAR | Standard Deviation 0.1052 |
| Control (Delefilcon A) | Binocular logMAR Visual Acuity | Intermediate (64cm) | -0.013 LogMAR | Standard Deviation 0.0934 |
Comparison: It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1.25% individually) with at least 90% statistical power, that 22 subjects were required to test for superiority for distance.98.75% CI: [-0.14, -0.01]Linear Mixed Model
Comparison: It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1.25% individually) with at least 90% statistical power, that 12 subjects were required to test for superiority for intermediate.98.75% CI: [-0.06, 0.07]Linear Mixed Model
Comparison: It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1.25% individually) with at least 90% statistical power, that 60 subjects were required to test for superiority for near.98.75% CI: [0.02, 0.16]Linear Mixed Model
Primary
CLUE Vision Score
Subjective vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patientreported 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 study or deviation from protocol, with data at the 1-Week Follow-up Evaluation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test (Senofilcon A C3) | CLUE Vision Score | 49.80 Units on a scale | Standard Deviation 19.662 |
| Control (Delefilcon A) | CLUE Vision Score | 52.35 Units on a scale | Standard Deviation 19.212 |
Comparison: It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1.25% individually) with at least 99% statistical power, that 13 subjects were required to test for superiority for CLUE vision scores.98.75% CI: [43.1, 58.5]Linear Mixed Model
Secondary
Binocular Distance logMAR Visual Acuity
Binocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale at distance (4m) under high luminance high contrast condition assessed using ETDRS (Early Treatment Diabetic Retinopathy Study) 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: 1-Week Follow-up
Population: All subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test (Senofilcon A C3) | Binocular Distance logMAR Visual Acuity | -0.078 LogMAR | Standard Deviation 0.0942 |
| Control (Delefilcon A) | Binocular Distance logMAR Visual Acuity | -0.083 LogMAR | Standard Deviation 0.108 |
Comparison: It was calculated using a 2 independent sample means t-test with a 2-sided type I error rate of 5% with at least 95% statistical power, that 60 subjects were required to test for non-inferiority of the Test compared to the Control for distance (4m).95% CI: [-0.05, 0.05]Linear Mixed Model