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The study is a bilateral, single-masked, single-arm, 3-visit dispensing study. There will be one study treatment, with the subject being in the treatment for approximately 12-16 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Lens | Experimental | Subjects between the ages 40 to 70 years of age and who are adapted contact lens wearers with astigmatism in both eyes will be assigned to the same Test Lens according to the lens wear schedule. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toric Multifocal etafilcon A with PVP | Device | Investigational |
|
| Measure | Description | Time Frame |
|---|---|---|
| Distance Visual Acuity (logMAR) | High Luminance, high contrast distance (4 meters) binocular visual acuity was recorded with the test contact lenses using ETDRS visual acuity charts. The logMAR visual acuity was measured as follows: 0.02 logMAR=1 letter. Where lower logMAR scores represent better vision. A value of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity. | 2-Week Follow-up |
| Near Visual Acuity (logMAR) | High Luminance, high contrast near (40 centimeters) binocular visual acuity was recorded with the test contact lenses using ETDRS visual acuity charts. The logMAR visual acuity was measured as follows:0.02 logMAR=1 letter. Where lower logMAR scores represent better vision. A value of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity. | 2-Week Follow-up |
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Inclusion Criteria:
Potential subjects must satisfy all of 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 and not more than 70 years of age at the time of screening.
The subject's distance spherical component of their refraction must be in the range of +1.25 D to +3.75 D in each eye.
The subject's refractive cylinder must be -1.00 to -1.50 D in each eye.
The subject's ADD power must be in the range of +0.75 D to +1.50 D in each eye.
Subject's refractive cylinder axis must be within 90°±30° or 180°±30° in each eye.
The subject must have best corrected visual acuity of 20/20-3 or better in each eye.
Subjects must own a wearable pair of spectacles if required for their distance vision.
The subject must 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".
Exclusion Criteria:
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Total Eye Care PA | Memphis | Tennessee | 38119 | United States |
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In total, 30 subjects were enrolled in this study of which, 28 subjects were assigned and dispensed a study lens, while 2 subjects failed to meet all eligibility criteria. Of the total dispensed subjects, 25 completed the study and 3 subjects were discontinued.
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| ID | Title | Description |
|---|---|---|
| FG000 | Toric Multifocal Etafilcon A With PVP | All subjects that were disepnsed the sudy lens. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Toric Multifocal Etafilcon A With PVP | All subjects dispensed a study lens. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Distance Visual Acuity (logMAR) | High Luminance, high contrast distance (4 meters) binocular visual acuity was recorded with the test contact lenses using ETDRS visual acuity charts. The logMAR visual acuity was measured as follows: 0.02 logMAR=1 letter. Where lower logMAR scores represent better vision. A value of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity. | All sub jects that completed all planned study visits without a major protocol deviation impacting a primary endpoint. | Posted | Mean | Standard Deviation | logMAR | 2-Week Follow-up |
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Throughout the duration of the study. Approximately 2 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 | Toric Multifocal Etafilcon A With PVP | All subjects dispensed a stud lens. | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas R. Karkkainen, OD, MS, FAAO- Sr. Principal Research Optometrist | Johnson & Johnson Vision Care Inc. | 1-800-843-2020 | TKarkkai@its.jnj.com |
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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 | Jul 12, 2018 | Feb 16, 2022 | Prot_SAP_000.pdf |
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Although study includes one arm, Participant is masked to the identity of the investigational product.
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| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
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|
| Primary | Near Visual Acuity (logMAR) | High Luminance, high contrast near (40 centimeters) binocular visual acuity was recorded with the test contact lenses using ETDRS visual acuity charts. The logMAR visual acuity was measured as follows:0.02 logMAR=1 letter. Where lower logMAR scores represent better vision. A value of 0.0 logMAR is equivalent to 20/20 Snellen visual acuity. | All subjects that completed all planned study visits without a major protocol deviation impacting a primary endpoint. | Posted | Mean | Standard Deviation | logMAR | 2-Week Follow-up |
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| 28 |
| 0 |
| 28 |
| 0 |
| 28 |
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