Visual Acuity
Conditions
Brief summary
This is a single-masked, single-arm, dispensing clinical trial that will evaluate vision, eye health and fit acceptance.
Interventions
DEVICEJJVC Investigational Multifocal Contact Lenses manufactured in senofilcon A C3
TEST Lens
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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 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 (vertex corrected if ≥-4.25 D) must be in the range of -1.25 D to -5.75 D or +0.75 D to +3.25 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, dacryocystorhinostomy, peripheral iridotomy/iridectomy, 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 section 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 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 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 |
|---|---|---|
| Proportion of Eyes With Grade 3 or Higher Slit Lamp Findings | Up to 1-Week Follow-up | Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at every study visit (baseline, unscheduled visits and 1-week follow-up). The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The proportion of eyes with SLF with grade 3 or higher was reported. |
| 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 patient-reported 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 sphere stratum (Hyperope and Myope) was reported. |
| Proportion of Eyes With Unacceptable Lens Fitting | Up to 1-Week Follow-up | Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope post lens insertion, the 1-week follow-up and any unscheduled visits. Lens fit was a binary variable where acceptable lens fit=1 and unacceptable lens fit=0. The proportion of eyes with unacceptable lens fit was reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CLUE Vision Score | 1-Week Follow-up | Subjective vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported 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 sphere stratum (Hyperope and Myope) was reported. |
| CLUE Comfort Score | 1-Week Follow-up | Subjective comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported 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 comfort score was reported. The pre-specified aim was not to compare comfort between the hyperope and myope subgroups, therefore, comfort scores were reported for both groups combined. |
| CLUE Handling Score | 1-Week Follow-up | Subjective Handling was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported 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 handling score was reported. The pre-specified aim was not to compare comfort between the hyperope and myope subgroups, therefore, comfort scores were reported for both groups combined. |
| Proportion of Subject Achieving Optimal Lens Pair in 4 Lenses or Less | Up to 1-Week Follow-up | The number of lenses to achieve the optimal pair for each subject was calculated as the original pair (2) plus all the required modifications to reach the optimal pair. In this study the minimum number of lenses per subject used was 2 where the maximum possible number of lenses used was 10. The data was dichotomized as Y=1 if the subject was able to achieve optimal lens pair in 4 lenses or lenses or less and 0 otherwise. A lens modification was performed if the subject reports unsatisfactory vision or was unable to obtain 20/30 distance visual acuity in both eyes. If the subject reported satisfactory vision with the lenses a modification was not required. However, based upon the investigator's findings on the measured visual acuity and/or over- refraction a modification may have been performed. |
Countries
United States
Participant flow
Recruitment details
A total of 140 subjects were enrolled in this study. Of those enrolled, 139 subjects were dispensed at least one study lens, while 1 subject failed to meet all eligibility criteria. Of those dispensed, 136 subjects completed the study while 3 subjects were discontinued.
Participants by arm
| Arm | Count |
|---|---|
| Hyperopes Subjects were classified as Hyperopic if the distance spherical equivalent refraction was in the range of +0.75 D to +3.25 D. | 50 |
| Myopes Subjects were classified as Myopic if the distance spherical equivalent refraction was in the range of -5.75 D to -1.25 D. | 89 |
| Total | 139 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | COVID-19 Related | 1 |
| Overall Study | Unsatisfactory Visual Response due to Test Article | 1 |
| Overall Study | Withdrew Consent during Study | 1 |
Baseline characteristics
| Characteristic | Myopes | Total | Hyperopes |
|---|---|---|---|
| Age, Continuous | 50.4 Years STANDARD_DEVIATION 6.14 | 51.7 Years STANDARD_DEVIATION 6.76 | 54.1 Years STANDARD_DEVIATION 7.2 |
| Race/Ethnicity, Customized Asian | 3 Participants | 5 Participants | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 9 Participants | 11 Participants | 2 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 2 Participants | 4 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 75 Participants | 119 Participants | 44 Participants |
| Region of Enrollment United States | 89 Participants | 139 Participants | 50 Participants |
| Sex: Female, Male Female | 66 Participants | 111 Participants | 45 Participants |
| Sex: Female, Male Male | 23 Participants | 28 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 139 |
| other Total, other adverse events | 0 / 139 |
| serious Total, serious adverse events | 0 / 139 |
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 dispensed subjects regardless of deviation from protocol with data collected at the 1-week follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test (Senofilcon A C3) | Binocular logMAR Visual Acuity | Distance(4m) | -0.098 LogMAR | Standard Deviation 0.0854 |
| Test (Senofilcon A C3) | Binocular logMAR Visual Acuity | Intermediate (64cm) | -0.043 LogMAR | Standard Deviation 0.0797 |
| Test (Senofilcon A C3) | Binocular logMAR Visual Acuity | Near (40cm) | 0.0797 LogMAR | Standard Deviation 0.1077 |
Comparison: It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1% Individually) with at least 99% statistical power, that 17 subjects were required to test the primary hypothesis for Distance.99% CI: [-0.12, -0.08]
Comparison: It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1% Individually) with at least 99% statistical power, that 11 subjects were required to test the primary hypothesis for Intermediate.99% CI: [-0.06, -0.02]
Comparison: It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1% Individually) with at least 99% statistical power, that 48 subjects were required to test the primary hypothesis for Near.99% CI: [0.05, 0.09]
Primary
CLUE Vision Score
Subjective vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported 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 sphere stratum (Hyperope and Myope) was reported.
Time frame: 1-Week Follow-up
Population: All dispensed subjects regardless of deviation from protocol with data collected at the 1-week follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test (Senofilcon A C3) | CLUE Vision Score | Hyperopes | 52.30 Units on a scale | Standard Deviation 19.121 |
| Test (Senofilcon A C3) | CLUE Vision Score | Myopes | 63.27 Units on a scale | Standard Deviation 19.031 |
Comparison: It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1% individually) with at least 99% statistical power, that 14 subjects were required to test for superiority for CLUE vision scores for Hyperopes.99% CI: [45.2, 59.4]
Comparison: It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1% individually) with at least 99% statistical power, that 18 subjects were required to test for superiority for CLUE vision scores for Myopes.99% CI: [58, 68.6]
Primary
Proportion of Eyes With Grade 3 or Higher Slit Lamp Findings
Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at every study visit (baseline, unscheduled visits and 1-week follow-up). The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The proportion of eyes with SLF with grade 3 or higher was reported.
Time frame: Up to 1-Week Follow-up
Population: All dispensed subjects regardless of subsequent withdrawal from study or deviation from protocol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test (Senofilcon A C3) | Proportion of Eyes With Grade 3 or Higher Slit Lamp Findings | 0 Porportion of eyes |
Comparison: It was calculated using a Bayesian beta-binomial model for correlated data with a reference rate of 0.02 and an intraclass correlation of 0.70 with 2000 replicating trials, that 100 subjects were required to test for superiority to achieve a minimum statistical power of 90% with 95% central posterior credible.95% CI: [0, 0.0078]Bayesian beta-binomial model
Primary
Proportion of Eyes With Unacceptable Lens Fitting
Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope post lens insertion, the 1-week follow-up and any unscheduled visits. Lens fit was a binary variable where acceptable lens fit=1 and unacceptable lens fit=0. The proportion of eyes with unacceptable lens fit was reported.
Time frame: Up to 1-Week Follow-up
Population: All dispensed subjects regardless of subsequent withdrawal from study or deviation from protocol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test (Senofilcon A C3) | Proportion of Eyes With Unacceptable Lens Fitting | 0 Proportion of eyes |
Comparison: It was calculated using a Bayesian beta-binomial model for correlated data with a reference rate of 0.02 and an intraclass correlation of 0.70 with 2000 replicating trials, that 100 subjects were required to test for superiority to achieve a minimum statistical power of 90% with 95% central posterior credible.95% CI: [0, 0.0076]Bayesian beta- binomial model
Secondary
CLUE Comfort Score
Subjective comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported 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 comfort score was reported. The pre-specified aim was not to compare comfort between the hyperope and myope subgroups, therefore, comfort scores were reported for both groups combined.
Time frame: 1-Week Follow-up
Population: All dispensed subjects regardless of deviation from protocol with data collected at the 1-week follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test (Senofilcon A C3) | CLUE Comfort Score | 72.60 Units on a scale | Standard Deviation 20.696 |
Comparison: It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1% individually) with at least 80% statistical power, that 11 subjects were required to test for superiority for CLUE comfort scores.99% CI: [68.1, 77.1]
Secondary
CLUE Handling Score
Subjective Handling was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported 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 handling score was reported. The pre-specified aim was not to compare comfort between the hyperope and myope subgroups, therefore, comfort scores were reported for both groups combined.
Time frame: 1-Week Follow-up
Population: All dispensed subjects regardless of deviation from protocol with data collected at the 1-week follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test (Senofilcon A C3) | CLUE Handling Score | 67.56 Units on a scale | Standard Deviation 20.619 |
Comparison: It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1% individually) with at least 80% statistical power, that 17 subjects were required to test for superiority for CLUE handling scores.99% CI: [63, 72.1]
Secondary
CLUE Vision Score
Subjective vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported 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 sphere stratum (Hyperope and Myope) was reported.
Time frame: 1-Week Follow-up
Population: All dispensed subjects regardless of deviation from protocol with data collected at the 1-week follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test (Senofilcon A C3) | CLUE Vision Score | Hyperopes | 52.30 Units on a scale | Standard Deviation 19.121 |
| Test (Senofilcon A C3) | CLUE Vision Score | Myopes | 63.27 Units on a scale | Standard Deviation 19.031 |
Comparison: It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1% individually) with at least 80% statistical power, that 16 subjects were required to test for superiority for CLUE vision scores for Hyperopes.99% CI: [45.2, 59.4]
Comparison: It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1% individually) with at least 80% statistical power, that 15 subjects were required to test for superiority for CLUE vision scores for Myopes.99% CI: [58, 68.6]
Secondary
Proportion of Subject Achieving Optimal Lens Pair in 4 Lenses or Less
The number of lenses to achieve the optimal pair for each subject was calculated as the original pair (2) plus all the required modifications to reach the optimal pair. In this study the minimum number of lenses per subject used was 2 where the maximum possible number of lenses used was 10. The data was dichotomized as Y=1 if the subject was able to achieve optimal lens pair in 4 lenses or lenses or less and 0 otherwise. A lens modification was performed if the subject reports unsatisfactory vision or was unable to obtain 20/30 distance visual acuity in both eyes. If the subject reported satisfactory vision with the lenses a modification was not required. However, based upon the investigator's findings on the measured visual acuity and/or over- refraction a modification may have been performed.
Time frame: Up to 1-Week Follow-up
Population: All dispensed subjects regardless of subsequent withdrawal from study or deviation from protocol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test (Senofilcon A C3) | Proportion of Subject Achieving Optimal Lens Pair in 4 Lenses or Less | 1 Proportion of subjects |
Comparison: It was calculated using a Bayesian beta-binomial model for correlated data with a reference rate of 0.98 and an intraclass correlation of 0.70 with 2000 replicating trials, that 92 subjects were required to test for superiority to achieve a minimum statistical power of 80% with 99% central posterior credible.99% CI: [0.959, 0.997]Bayesian beta-binomial model