Visual Acuity
Conditions
Brief summary
The clinical study is a bilateral, single-masked (partial), single-arm, clinical trial. A total of approximately 60 eligible subjects both near-sighted and far-sighted, will be targeted to complete the study. Subjects will be fit in the study lens for approximately 2-4 days then undergo lens optimization, if required. Subjects will then be given a new pair of lenses that will be worn for approximately 2 weeks.
Interventions
TEST Lens
DEVICEACUVUE OASYS® with HYDRACLEAR® PLUS
The spherical test lens was used in the troubleshooting steps only for low ADD subjects who have reported a distance vision complaint.
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Participant is masked to the brand of the devices
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
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 years of age and not greater than 70 years of age at the time of consent. 4. Subjects must own a wearable pair of spectacles if required for their distance vision. 5. The subject must be an adapted soft contact lens wearer in both eyes (i.e. wears lenses a minimum of 2 days per week for at least 6 hours per wear day, for 1 month of more duration). 6. The subject must 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 (Appendix E). 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
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. 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. A history of amblyopia, strabismus or binocular vision abnormality. 6. History of glaucoma, macular degeneration, recurrent corneal erosions, recurrent styes, herpetic keratitis, irregular cornea or pathological dry eye. 7. Use of any of the following medications within 1 week prior to enrollment: oral retinoids, oral tetracyclines, oral phenothiazines, anticholinergics, corticosteroids. 8. Use of any ocular medication, with the exception of rewetting drops. 9. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment. 10. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician). 11. Any known hypersensitivity or allergic reaction to Optifree® Replenish® multipurpose care solution, sodium fluorescein or non-preserved rewetting drop solutions. 12. 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. 13. Any current ocular infection or inflammation. 14. Any current ocular abnormality that may interfere with contact lens wear.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vision Scores | 2-Week Follow-up | Overall vision scores were 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. |
| Visual Performance LogMAR | 2-Week Follow-up | Binocular visual performance on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4m), intermediate (64cm) and near (40cm) under high luminance high contrast lighting condition using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. The room illuminance was required to be between 7.3 to 7.9 EV (394-597 lux). For Distance (4m), the acceptable range for the chart luminance was 10.5-10.7 EV (181 208 cd/m2). For Intermediate (64cm) and Near (40cm), the acceptable range for the chart luminance 10.8-11.1 EV (223-274 cd/m2). Letter-by-letter results calculated the visual performance score for each chart read. A logMAR score closer to zero, or below zero, indicates a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20. Data from hyperopes and myopes were combined for this outcome since logMAR scores between the two populations are similar. |
| Proportion of Eyes With Unacceptable Lens Fitting | Up to 2-Week Follow-up | Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope post lens insertion and the 2-week follow-up. 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. Data from the hyperope and myopes group were combined for this outcome since lens fitting characteristerics are similar for these two populations. |
| Proportion of Eyes With Grade 3 or Higher Slit Lamp Findings | Up to 2-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 2-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. Data from the hyperope and myopes group were combined for this outcome since the rate of SLFs grade 3 + is similar for both populations. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Eyes That Achieved Optimal Lens Pair in 4 Lenses or Less | Up to 2-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 12. 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. Data for the hyperope and myope groups were combined for this endpoint since the number of lenses needed to optimize vision is indpendent of which group a subject belongs to. |
Countries
United States
Participant flow
Recruitment details
A total of 119 subjects were enrolled into this study. Of those enrolled, 114 subjects were dispensed a study lens while 4 subjects failed to meet all eligibility criteria. Of those dispensed, 110 completed the study while 4 subjects were discontinued.
Participants by arm
| Arm | Count |
|---|---|
| Hyperopes All subjects dispensed a study lens. | 55 |
| Myopes All subjects dispensed a study lens. | 59 |
| Total | 114 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | COVID-19 Related | 1 |
| Overall Study | Unsatisfactory Visual Response due to Test Article | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Myopes | Total | Hyperopes |
|---|---|---|---|
| Age, Continuous | 50.5 years STANDARD_DEVIATION 6.21 | 53.5 years STANDARD_DEVIATION 7.21 | 56.8 years STANDARD_DEVIATION 6.78 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 participants | 1 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 | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized White | 56 participants | 106 participants | 50 participants |
| Region of Enrollment United States | 59 participants | 114 participants | 55 participants |
| Sex: Female, Male Female | 48 Participants | 97 Participants | 49 Participants |
| Sex: Female, Male Male | 11 Participants | 17 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 114 |
| other Total, other adverse events | 0 / 114 |
| serious Total, serious adverse events | 0 / 114 |
Outcome results
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 2-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. Data from the hyperope and myopes group were combined for this outcome since the rate of SLFs grade 3 + is similar for both populations.
Time frame: Up to 2-Week Follow-up
Population: All subjects were dispensed at least one study lens.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Senofilcon A (Investigational Multifocal Lens) | Proportion of Eyes With Grade 3 or Higher Slit Lamp Findings | 0 proportion of eyes |
95% CI: [0, 0.018]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 and the 2-week follow-up. 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. Data from the hyperope and myopes group were combined for this outcome since lens fitting characteristerics are similar for these two populations.
Time frame: Up to 2-Week Follow-up
Population: All subjects were dispensed at least one study lens.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Senofilcon A (Investigational Multifocal Lens) | Proportion of Eyes With Unacceptable Lens Fitting | 0 proportion of eyes |
95% CI: [0, 0.004]Bayesian beta-binomial model
Primary
Vision Scores
Overall vision scores were 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: 2-Week Follow-up
Population: All subjects that completed all study visits without a major protocol deviation impacting a primary endpoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Senofilcon A (Investigational Multifocal Lens) | Vision Scores | Myopes | 61.97 CLUE points | Standard Deviation 20.671 |
| Senofilcon A (Investigational Multifocal Lens) | Vision Scores | Hyperopes | 57.48 CLUE points | Standard Deviation 21.175 |
Comparison: It was calculated that 60 participants would have \> 99% power to for the mean CLUE vision scores for each sphere stratum to be above the hypothesis threshold at the 2-week follow-up. Sample size was determined using one sample means test for equivalence95% CI: [52.3, 64.9]Bayesian multivariate random-effects
Comparison: It was calculated that 60 participants would have \> 99% power to for the mean CLUE vision scores for each sphere stratum to be above the hypothesis threshold at the 2-week follow-up. Sample size was determined using one sample means test for equivalence95% CI: [57.9, 69.6]Bayesian multivariate random-effects
Primary
Visual Performance LogMAR
Binocular visual performance on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4m), intermediate (64cm) and near (40cm) under high luminance high contrast lighting condition using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. The room illuminance was required to be between 7.3 to 7.9 EV (394-597 lux). For Distance (4m), the acceptable range for the chart luminance was 10.5-10.7 EV (181 208 cd/m2). For Intermediate (64cm) and Near (40cm), the acceptable range for the chart luminance 10.8-11.1 EV (223-274 cd/m2). Letter-by-letter results calculated the visual performance score for each chart read. A logMAR score closer to zero, or below zero, indicates a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20. Data from hyperopes and myopes were combined for this outcome since logMAR scores between the two populations are similar.
Time frame: 2-Week Follow-up
Population: All subjects that completed all study visits without a major protocol deviation impacting a primary endpoint. Hyperopes and myopes were combined based on historical data for subjects in this study with regard to visual performance logMAR.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Senofilcon A (Investigational Multifocal Lens) | Visual Performance LogMAR | Distance (4M) | -0.09 logMAR | Standard Deviation 0.105 |
| Senofilcon A (Investigational Multifocal Lens) | Visual Performance LogMAR | Intermediate (64 cm) | -0.06 logMAR | Standard Deviation 0.084 |
| Senofilcon A (Investigational Multifocal Lens) | Visual Performance LogMAR | Near (40 cm) | 0.06 logMAR | Standard Deviation 0.086 |
Comparison: It was calculated that 60 participants would have \> 99% power to for the mean visual performance at each distance to be below the hypothesis threshold at the 2-week follow-up. Sample size was determined using one sample means test for equivalence95% CI: [-0.125, -0.057]Bayesian normal random-effects model
Comparison: It was calculated that 60 participants would have \> 99% power to for the mean visual performance at each distance to be below the hypothesis threshold at the 2-week follow-up. Sample size was determined using one sample means test for equivalence95% CI: [-0.091, -0.024]Bayesian normal random-effects model
Comparison: It was calculated that 60 participants would have \> 99% power to for the mean visual performance at each distance to be below the hypothesis threshold at the 2-week follow-up. Sample size was determined using one sample means test for equivalence95% CI: [0.031, 0.098]Bayesian normal random-effects model
Secondary
Proportion of Eyes That Achieved 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 12. 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. Data for the hyperope and myope groups were combined for this endpoint since the number of lenses needed to optimize vision is indpendent of which group a subject belongs to.
Time frame: Up to 2-Week Follow-up
Population: All subjects were dispensed at least one study lens.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Senofilcon A (Investigational Multifocal Lens) | Proportion of Eyes That Achieved Optimal Lens Pair in 4 Lenses or Less | 0.4 proportion of eyes |
95% CI: [0.973, 0.999]Bayesian beta-binomial model