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This is a 6-visit, subject-masked, multi-site, 2×3 crossover dispensing trial that will last approximately 2 - 4 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test/Control/Control | Experimental | Eligible subjects that are habitual soft contact lens wearers will be randomized to lens wear sequence, (Test/Control/Control) |
|
| Control/Test/Test | Experimental | Eligible subjects that are habitual soft contact lens wearers will be randomized to lens wear sequence, (Control/Test/Test) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JJVC Investigational Multifocal Contact Lens | Device | TEST Lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Performance LogMAR | Binocular visual performance on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4 meters), intermediate (64 centimeters) and near (40 centimeters) 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 meters), 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. 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. | 1-Week Follow-up within each wearing period |
| Measure | Description | Time Frame |
|---|---|---|
| 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 leans type was reported. |
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Inclusion Criteria:
Potential subjects must satisfy all the following criteria to be enrolled in the study:
The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
The subject must be at least 40 years of age and not greater than 70 years of age at the time of consent.
Subjects must own a wearable pair of spectacles if required for their distance vision.
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).
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).
The subject's distance spherical equivalent refraction must be in the range of -1.25 D to -3.75 D in each eye.
The subject's refractive cylinder must be ≤0.75 D in each eye.
The subject's ADD power must be in the range of +0.75 D to +2.50 D.
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:
Currently pregnant or lactating.
Any active or ongoing ocular or systemic allergies that may interfere with contact lens wear.
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).
Any previous, or planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, lid procedures, cataract surgery, retinal surgery, etc.).
A history of amblyopia, strabismus or binocular vision abnormality.
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.
Use of any ocular medication, with the exception of rewetting drops.
History of herpetic keratitis.
History of irregular cornea.
History of pathological dry eye.
Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
Any known hypersensitivity or allergic reaction to non-preserved rewetting drop solutions or sodium fluorescein.
Exclusion Criteria after Baseline:
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.
Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions.
Any current ocular infection or inflammation.
Any current ocular abnormality that may interfere with contact lens wear
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vue Optical Boutique | Jacksonville | Florida | 32205 | United States | ||
| Visual Eyes, Inc. |
Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
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A total of 71 subject were enrolled into this study. Of those enrolled, 68 were dispensed at least one study lens while 3 subjects failed to meet all eligibility criteria. Of those dispensed, 60 completed the study while 8 subjects were discontinued.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test/Control/Control | Subjects that wore the Test lens in a bilateral fashion during period 1 and the Control lens during both the second and third study periods. |
| FG001 | Control/Test/Test |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 5, 2020 |
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| Dailies Total 1® Multifocal Contact Lens | Device | CONTROL Lens |
|
| 1-Week Follow-up within each wearing period |
| Roswell |
| Georgia |
| 30075 |
| United States |
| Advanced Eye Care | Raytown | Missouri | 64133 | United States |
| Susquehanna Eye Care | Vestal | New York | 13850 | United States |
| ProCare Vision Centers | Granville | Ohio | 43023 | United States |
| West Bay Eye Associates | Warwick | Rhode Island | 02888 | United States |
Subjects that wore the Control lens in a bilateral fashion during period 1 and the Test lens during the second and third study periods.
| COMPLETED |
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| NOT COMPLETED |
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| Period 2 |
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| Period 3 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Test/Control/Control | Subjects that wore the Test lens in a bilateral fashion during period 1 and the Control lens during both the second and third study periods. |
| BG001 | Control/Test/Test | Subjects that wore the Control lens in a bilateral fashion during period 1 and the Test lens during the second and third study periods. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Visual Performance LogMAR | Binocular visual performance on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4 meters), intermediate (64 centimeters) and near (40 centimeters) 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 meters), 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. 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. | All subjects that completed all study visits without a major protocol deviation impacting a primary endpoint. | Posted | Mean | Standard Deviation | logMAR | 1-Week Follow-up within each wearing period | Observations | Observations |
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| Secondary | 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 leans type was reported. | All subjects that completed all study visits without a major protocol deviation impacting a primary endpoint. | Posted | Mean | Standard Deviation | units on a scale | 1-Week Follow-up within each wearing period | Observations | Observations |
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Throughout the duration of the study; approximately 3 weeks per subject.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Test | All subjects that wore the Test lens during any of the 3 study periods. | 0 | 67 | 0 | 67 | 0 | 67 |
| EG001 | Control | All subjects that wore the Control lens during any of the 3 study periods. | 0 | 66 | 0 | 66 | 0 | 66 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Karkkainen- Sr. Research Principal Optometrist | Johnson & Johns Vision Care Inc. | 1-800-843-2020 | tkarkkai@its.jnj.com |
| Dec 8, 2021 |
| Prot_SAP_000.pdf |
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| Withdrawal by Subject |
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| Adverse Event |
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| Male |
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| White |
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| Near (40cm) |
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| Linear Mixed Model |
Kenward and Roger Method was used for denominator degrees of freedom. |
| Mean estimate |
| -0.066 |
| Standard Error of the Mean |
| 0.0202 |
| 2-Sided |
| 95 |
| -0.115 |
| -0.017 |
| Superiority |
The superiority of the Test lens will be concluded if the upper confidence limit of the mean is below the predefined threshold +0.17 logMAR for Intermediate. |
| Linear Mixed Model | Kenward and Roger Method was used for denominator degrees of freedom. | Mean estimate | 0.072 | Standard Error of the Mean | 0.0217 | 2-Sided | 95 | 0.022 | 0.121 | Superiority | The superiority of the Test lens will be concluded if the upper confidence limit of the mean is below the predefined threshold +0.17 logMAR for Near. |
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| Observations |
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