Visual Acuity
Conditions
Brief summary
The study is a bilateral, single-masked, single-arm, 4-visit dispensing study. There will be one study treatment, with the subject being dispensed lenses for 6 to 8 days, then lens power will be optimized (if necessary) and dispensed for a further 2 weeks to assess the clinical performance of investigational multifocal toric contact lenses.
Interventions
DEVICEJJVC Investigational Multifocal Toric Contact Lens
TEST
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Subjects will be masked to the study lens to help reduce potential bias. Subjects will be unaware of 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. 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. worn lenses for at least 8 hours per day at least two days per week for the past 4 weeks). 6. Be already 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 component of their refraction must be in the range of either -1.25 D to -3.75 D, or +1.25 D to +3.75 D. 8. The subject's refractive cylinder must be -1.00 D to -1.50 D in each eye, with the cylinder axes in the range of 90°±30°. 9. The subject's ADD power must be in the range of +0.75 D to +2.50 D in each eye. 10. The subject must have best corrected distance 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. By self-report, have any systemic disease (e.g. Sjögren's Syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study. 3. Use systemic medications that may interfere with contact lens wear or cause blurred vision. 4. Currently use ocular medication (with the exception of rewetting drops). 5. Have any known hypersensitivity or allergic reaction to single use preservative free rewetting drops or sodium fluorescein. 6. Have had any previous, or have any planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, cataract surgery, retinal surgery, etc.). 7. Have had previous eyelid injuries, surgeries or procedures which are known to have caused abnormal eyelid position or movement, by self-report. 8. Have participated in any contact lens or lens care product clinical trial within 7 days prior to study enrollment. 9. Be an employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician). 10. Have a history of amblyopia or strabismus, by self-report. 11. Have a history of herpetic keratitis, by self-report. 12. Have ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion. 13. Have any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA scale.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Vision | 2-Week Follow-up | Overall 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. |
| LogMAR Visual Acuity | 2-Week Follow-up | Binocular visual performance on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4 m),intermediate (64 cm) and near (40 cm) 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 and 7.9 EV (394-597 lux). For Distance (4 m), 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. Hyperopes and myopes were combined based on historical data for subjects in this study with regard to visual performance logMAR. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline CLUE Vision Score | Up to 2-Week Follow-up | Overall 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 change from baseline was calculated as the 2 week follow-up scores minus baseline scores. Change from baseline scores range from -120 to 120, where higher change from baseline scores indicate better performance. The average change from baseline was reported. |
| Change From Baseline CLUE Comfort Score | Up to 2-Week Follow-up | Overall 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 change from baseline was calculated as the 2- week follow-up scores minus baseline scores. Change from baseline scores range from -120 to 120, where higher change from baseline scores indicate better performance. The average change from baseline was reported. |
| Change From Baseline CLUE Handling Score | Up to 2-Week Follow-up | Overall 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 change from baseline was calculated as the 2- week follow-up scores minus baseline scores. Change from baseline scores range from -120 to 120, where higher change from baseline scores indicate better performance. The average change from baseline was reported. |
Countries
United States
Participant flow
Recruitment details
A total of 95 subjects were enrolled into this study. Of those enrolled, 86 were dispensed study lenses, while 9 subjects failed to meet all eligibility criteria. Of those dispensed, 84 completed the study while 2 subjects were discontinued.
Participants by arm
| Arm | Count |
|---|---|
| Myope subjects were classified as Myopic if the distance spherical component of their refractive error was in the range of -1.25 D to -3.75 D | 48 |
| Hyperope subjects were classified as Hyperopic if the distance spherical component of their refractive error was in the range of +1.25 D to +3.75 D | 38 |
| Total | 86 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lens discomfort | 1 |
| Overall Study | Unsatisfactory lens fitting due to test article | 1 |
Baseline characteristics
| Characteristic | Total | Myope | Hyperope |
|---|---|---|---|
| Age, Continuous | 52.2 Years STANDARD_DEVIATION 7.88 | 48.5 Years STANDARD_DEVIATION 6.28 | 56.7 Years STANDARD_DEVIATION 7.36 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 9 Participants | 4 Participants | 5 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 75 Participants | 43 Participants | 32 Participants |
| Region of Enrollment United States | 86 Participants | 48 Participants | 38 Participants |
| Sex: Female, Male Female | 62 Participants | 35 Participants | 27 Participants |
| Sex: Female, Male Male | 24 Participants | 13 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 86 |
| other Total, other adverse events | 0 / 86 |
| serious Total, serious adverse events | 0 / 86 |
Outcome results
Primary
LogMAR Visual Acuity
Binocular visual performance on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4 m),intermediate (64 cm) and near (40 cm) 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 and 7.9 EV (394-597 lux). For Distance (4 m), 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. Hyperopes and myopes were combined based on historical data for subjects in this study with regard to visual performance logMAR.
Time frame: 2-Week Follow-up
Population: Subjects that completed the study without a major protocol deviation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Multifocal Toric Contact Lens in Senofilcon A (C3) With UV/HEV Blocker | LogMAR Visual Acuity | Distance (4M) | -0.12 LogMAR | Standard Deviation 0.083 |
| Multifocal Toric Contact Lens in Senofilcon A (C3) With UV/HEV Blocker | LogMAR Visual Acuity | Intermediate (64 cm) | -0.05 LogMAR | Standard Deviation 0.089 |
| Multifocal Toric Contact Lens in Senofilcon A (C3) With UV/HEV Blocker | LogMAR Visual Acuity | Near (40 cm) | 0.06 LogMAR | Standard Deviation 0.125 |
Comparison: It was calculated by using a 2-sided one sample mean t-test with a family wise type I error rate of 5% and at least 80% statistical power , 42 subjects were required to test superiority for distance (4m).95% CI: [-0.167, -0.091]Mixed Models Analysis
Comparison: It was calculated by using a 2-sided one sample mean t-test with a family wise type I error rate of 5% and at least 80% statistical power , 7 subjects were required to test superiority for intermediate (64 cm).95% CI: [-0.084, -0.008]Mixed Models Analysis
Comparison: It was calculated by using a 2-sided one sample mean t-test with a family wise type I error rate of 5% and at least 80% statistical power , 36 subjects were required to test superiority for near (40 cm).95% CI: [0.029, 0.105]Mixed Models Analysis
Primary
Overall Vision
Overall 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.
Time frame: 2-Week Follow-up
Population: Subjects that completed the study without a major protocol deviation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Multifocal Toric Contact Lens in Senofilcon A (C3) With UV/HEV Blocker | Overall Vision | Myope | 58.37 Units on a Scale | Standard Deviation 21.586 |
| Multifocal Toric Contact Lens in Senofilcon A (C3) With UV/HEV Blocker | Overall Vision | Hyperope | 53.53 Units on a Scale | Standard Deviation 21.16 |
Comparison: It was calculated using a 2-sided one sample means t-test with a family wise type I error rate of 5% and at least 80% statistical power, that 22 subjects were required to test superiority for myope.95% CI: [50.9, 65.4]Mixed Models Analysis
Comparison: It was calculated using a 2-sided one sample means t-test with a family wise type I error rate of 5% and at least 80% statistical power, that 18 subjects were required to test superiority for hyperope.95% CI: [47.2, 62.8]Mixed Models Analysis
Secondary
Change From Baseline CLUE Comfort Score
Overall 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 change from baseline was calculated as the 2- week follow-up scores minus baseline scores. Change from baseline scores range from -120 to 120, where higher change from baseline scores indicate better performance. The average change from baseline was reported.
Time frame: Up to 2-Week Follow-up
Population: Subjects that completed the study without a major protocol deviation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Multifocal Toric Contact Lens in Senofilcon A (C3) With UV/HEV Blocker | Change From Baseline CLUE Comfort Score | Myope | 6.85 Units on a Scale | Standard Deviation 22.912 |
| Multifocal Toric Contact Lens in Senofilcon A (C3) With UV/HEV Blocker | Change From Baseline CLUE Comfort Score | Hyperope | 3.30 Units on a Scale | Standard Deviation 25.123 |
Comparison: The study was only powered for the primary endpoint.95% CI: [0, 13.7]Mixed Models Analysis
Comparison: The study was only powered for the primary endpoint.95% CI: [-4.7, 11.3]Mixed Models Analysis
Secondary
Change From Baseline CLUE Handling Score
Overall 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 change from baseline was calculated as the 2- week follow-up scores minus baseline scores. Change from baseline scores range from -120 to 120, where higher change from baseline scores indicate better performance. The average change from baseline was reported.
Time frame: Up to 2-Week Follow-up
Population: Subjects that completed the study without a major protocol deviation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Multifocal Toric Contact Lens in Senofilcon A (C3) With UV/HEV Blocker | Change From Baseline CLUE Handling Score | Myope | 11.22 Units on a Scale | Standard Deviation 22.261 |
| Multifocal Toric Contact Lens in Senofilcon A (C3) With UV/HEV Blocker | Change From Baseline CLUE Handling Score | Hyperope | 10.02 Units on a Scale | Standard Deviation 20.553 |
Comparison: The study was only powered for the primary endpoint.95% CI: [5, 17.4]Mixed Models Analysis
Comparison: The study was only powered for the primary endpoint.95% CI: [2.8, 17.3]Mixed Models Analysis
Secondary
Change From Baseline CLUE Vision Score
Overall 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 change from baseline was calculated as the 2 week follow-up scores minus baseline scores. Change from baseline scores range from -120 to 120, where higher change from baseline scores indicate better performance. The average change from baseline was reported.
Time frame: Up to 2-Week Follow-up
Population: Subjects that completed the study without a major protocol deviation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Multifocal Toric Contact Lens in Senofilcon A (C3) With UV/HEV Blocker | Change From Baseline CLUE Vision Score | Myope | 8.40 Units on a Scale | Standard Deviation 18.163 |
| Multifocal Toric Contact Lens in Senofilcon A (C3) With UV/HEV Blocker | Change From Baseline CLUE Vision Score | Hyperope | 5.03 Units on a Scale | Standard Deviation 18.799 |
Comparison: The study was only powered for the primary endpoint.95% CI: [3.1, 13.7]Mixed Models Analysis
Comparison: The study was only powered for the primary endpoint.95% CI: [-1.2, 11.2]Mixed Models Analysis