Visual Acuity
Conditions
Brief summary
This is a 6-visit, subject-masked, multi-site, 2×3 crossover dispensing trial that will last approximately 2 - 4 months.
Interventions
DEVICEInvestigational senofilcon A C3 Multifocal Lens
TEST
DEVICEdelefilcon A Multifocal Lens
Dailies Total 1® Multifocal Contact Lens
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
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. 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. worn lenses a minimum of 2 days per week for at least 6 hours per wear day, for 1 month or 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 must be in the range of +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. 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, 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, cataract surgery, retinal surgery, etc.). 5. A history of amblyopia, strabismus or binocular vision abnormality. 6. Use of any of the following medications within 2 weeks prior to enrollment: oral retinoids, oral tetracyclines, anticholinergics, systemic/topical steroids, oral phenothiazines. See section 9.1 for additional details regarding excluded systemic medications. 7. Use of any ocular medication, with the exception of rewetting drops. 8. History of herpetic keratitis. 9. History of irregular cornea. 10. History of pathological dry eye. 11. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment. 12. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician). 13. Any known hypersensitivity or allergic reaction to non-preserved rewetting drop solutions or sodium fluorescein. 14. 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. Entropion, ectropion, extrusions, chalazia, recurrent styes, dry eye, glaucoma, history of recurrent corneal erosions. 16. Any current ocular infection or inflammation. 17. Any current ocular abnormality that may interfere with contact lens wear.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Binocular Visual Acuity (logMAR) | 1-Week Follow-up | Binocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale and was evaluated at distance (4 meters), intermediate (64 cm) and near (40 cm) under high lumiance high contrast lighting conditions using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. The room illuminance was required to be beetween 7.3 and 7.9 EV (394-597 lux). For Distance (4 meters), the acceptable range for the chart luminance was 10.5-10.7 EV (181-208 cd/m2). For Intermediate (64 cm) 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. 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Overall Vision Scores | 1- 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 patientexperience 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. |
Countries
United States
Participant flow
Recruitment details
A total of 81 subject were enrolled into this study. Of those enrolled, 78 were dispensed at least one study lens while 3 subjects failed to meet all eligibility criteria. Of those dispensed, 70 completed the study while 8 subjects were discontinued.
Participants by arm
| Arm | Count |
|---|---|
| All Dispensed Subjects All subjects dispensed at least one study lens | 78 |
| Total | 78 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 | Adverse Event | 0 | 2 |
| Period 1 | COVID-19 related | 1 | 0 |
| Period 1 | Protocol Violation | 0 | 1 |
| Period 2 | COVID-19 Related | 0 | 1 |
| Period 2 | Lost to Follow-up | 0 | 1 |
| Period 2 | Protocol Violation | 0 | 1 |
| Period 3 | Subject no longer meets eligibilty criteria | 1 | 0 |
Baseline characteristics
| Characteristic | All Dispensed Subjects |
|---|---|
| Age, Continuous | 56.6 Years STANDARD_DEVIATION 6.84 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Asian | 5 Participants |
| Race/Ethnicity, Customized Black or African American | 7 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race/Ethnicity, Customized Other | 2 Participants |
| Race/Ethnicity, Customized White | 63 Participants |
| Region of Enrollment United States | 78 Participants |
| Sex: Female, Male Female | 61 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 75 | 0 / 77 |
| other Total, other adverse events | 0 / 75 | 0 / 77 |
| serious Total, serious adverse events | 0 / 75 | 0 / 77 |
Outcome results
Primary
Binocular Visual Acuity (logMAR)
Binocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale and was evaluated at distance (4 meters), intermediate (64 cm) and near (40 cm) under high lumiance high contrast lighting conditions using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. The room illuminance was required to be beetween 7.3 and 7.9 EV (394-597 lux). For Distance (4 meters), the acceptable range for the chart luminance was 10.5-10.7 EV (181-208 cd/m2). For Intermediate (64 cm) 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. 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: Subjects that completed all study visits without a major protocol deviation impacting a primary or secondary endpoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test | Binocular Visual Acuity (logMAR) | Distance | -0.07 logMAR | Standard Deviation 0.083 |
| Test | Binocular Visual Acuity (logMAR) | Intermediate | -0.05 logMAR | Standard Deviation 0.087 |
| Test | Binocular Visual Acuity (logMAR) | Near | 0.07 logMAR | Standard Deviation 0.102 |
| Control | Binocular Visual Acuity (logMAR) | Near | 0.08 logMAR | Standard Deviation 0.095 |
| Control | Binocular Visual Acuity (logMAR) | Distance | -0.05 logMAR | Standard Deviation 0.084 |
| Control | Binocular Visual Acuity (logMAR) | Intermediate | -0.04 logMAR | Standard Deviation 0.08 |
Comparison: It was calculated that 70 participants would have at least 90% power to for the mean visual performance at each distance to be below the hypothesis threshold at the 1-week follow-up. Sample size was determined using one sample means test for equivalence95% CI: [-0.099, -0.057]Linear Mixed Model
Comparison: It was calculated that 70 participants would have at least 90% power to for the mean visual performance at each distance to be below the hypothesis threshold at the 1-week follow-up. Sample size was determined using one sample means test for equivalence95% CI: [-0.079, -0.039]Linear Mixed Model
Comparison: It was calculated that 70 participants would have at least 90% power to for the mean visual performance at each distance to be below the hypothesis threshold at the 1-week follow-up. Sample size was determined using one sample means test for equivalence95% CI: [0.04, 0.084]Linear Mixed Model
Secondary
Subjective Overall 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 patientexperience 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: Subjects that completed all study visits without a major protocol deviation impacting a primary or secondary endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test | Subjective Overall Vision Scores | 53.1 units on a scale | Standard Deviation 20.09 |
| Control | Subjective Overall Vision Scores | 55.2 units on a scale | Standard Deviation 18.9 |
Comparison: This study was powered to only test primary hypotheses.95% CI: [49.25, 62.61]Linear Mixed Model
Comparison: This study was powered for only the primary hypotheses.95% CI: [-5.893, -0.073]Linear Mixed Model