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This is a single-masked, bilateral, controlled, randomized, 2x2 crossover, non-dispensing clinical trial to characterize the effects of an HEV-Blocker on several measures of visual function in a presbyopic population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period 1 | Experimental | Eligible subjects will be randomly assigned to contact lens wear sequence TEST/CONTROL in a bilateral fashion. |
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| Period 2 | Experimental | Eligible subjects will be randomly assigned to contact lens wear sequence CONTROL/ TEST in a bilateral fashion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JJVC Investigational Multifocal Contact Lens TEST Lens | Device | TEST Lens |
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| Measure | Description | Time Frame |
|---|---|---|
| Starburst Diameter (mm) | The starburst diameter (mm) was measured each subject binocularly. Starburst diameter was quantified by the horizontal spread of the spokes emerging from the center of a small, point-like stimulus. A calibrated custom-made micrometer (two sides with reverse threading) was used to spread two posts out from a central mid-point. The posts attach to a custom-designed ruler that indicates the lateral spread of the starburst. Measurements for this metric are positive. Smaller diameter indicates better lens performance. The average diameter (mm) for each lens type was reported by period. | 30-minutes post lens insertion |
| Halos Diameter (mm) | Halo diameter (mm) was quantified and measured using the same micrometer as for starbursts diameter (mm). The Halo diameter (mm) was measured each subject binocularly. Measurements for halo diameter are positive, where smaller values indicate better performance. The average diameter (mm) for each lens type. | 30-minutes post lens insertion |
| Glare Disability Threshold | Glare disability threshold was collected binocularly for each subject. Subjects were exposed to a target stimulus for 2 seconds; before the measurement was taken the annulus was set to a level below that which would cause the target stimulus to be veiled. The experimenter would then adjust the intensity of the annulus until subjects could no longer see the target stimulus. Subjects would indicate this by pressing a buzzer. Glare disability thresholds take on positive values, where higher values indicate better lens performance. The average glare disability level (change in log relative energy) for each lens type was reported. | 30-minutes post lens insertion |
| Measure | Description | Time Frame |
|---|---|---|
| Glare Discomfort (mm) | The Glare discomfort was evaluated by calculating the change in height of the palpebral fissure measured while the participant views the mid-wave central grating target, compared to the maximal squint during a 5-second Photostress exposure induced by a solid, 10-degree broadband field, which completely obscures the target (~10-deg diameter). Both eyes were recorded and averaged, to produce an average palpebral fissure height before and during the Photostress exposure. Glare discomfort can take on negative and positive values, where smaller values indicate better lens performance. The average glare discomfort (change in palpebral fissure height) for each lens type was reported. |
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Inclusion Criteria:
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form
Appear able and willing to adhere to the instructions set forth in this clinical protocol.
Be between at least 40 and not more than 70 years of age at the time of screening.
Possess a wearable pair of spectacles that provide correction for distance vision.
Be an adapted soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 8 hours per wear day, for 1 month of more duration).
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".
The subject must have normal color perception as evidenced by reading 17 out of the first 21 Ishihara plates correctly.
The subject's distance spherical equivalent of their refraction must be in the range of -1.00 D to -4.00 D.
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 in each eye.
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:
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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Vision Care, Inc. Clinical Trial | Johnson & Johnson Vision Care, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Georgia | Athens | Georgia | 30602 | United States |
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 37 subjects were enrolled into this study. Of those enrolled, 35 were fit into at least 1 study lens, while 2 subjects failed to meet all eligibility criteria. Of those dispensed, 25 subjects completed the study, while 10 subjects were discontinued.
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| ID | Title | Description |
|---|---|---|
| FG000 | Senofilcon A\Senofilcon A (C3) | Subjects randomized to this sequence received the senofilcon A lens during the first period and then received the senofilcon A (C3) lens during the second period |
| FG001 | Senofilcon A (C3)\ Senofilcon A | Subjects randomized to this sequence received the senofilcon A (C3) lens during the first period and then received the senofilcon A lens during the second period |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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All subjects fitted at least one study lens.
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| ID | Title | Description |
|---|---|---|
| BG000 | Fitted Subjects | All subjects fitted at least one study lens. |
| 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 |
| 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 | Starburst Diameter (mm) | The starburst diameter (mm) was measured each subject binocularly. Starburst diameter was quantified by the horizontal spread of the spokes emerging from the center of a small, point-like stimulus. A calibrated custom-made micrometer (two sides with reverse threading) was used to spread two posts out from a central mid-point. The posts attach to a custom-designed ruler that indicates the lateral spread of the starburst. Measurements for this metric are positive. Smaller diameter indicates better lens performance. The average diameter (mm) for each lens type was reported by period. | All subjects fitted at least one study lens. | Posted | Mean | Standard Deviation | mm | 30-minutes post lens insertion |
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Throughout the duration of the study; approximately 5- 10 days 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 | Senofilcon A (C3) | Subjects that wore senofilcon A (C3) lens in either the first or second period of the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas R. Karkkainen, OD, MS, FAAO | Johnson & Johnson Vision Care, Inc. (JJVC) | 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 | Jan 12, 2022 | Apr 4, 2023 | Prot_SAP_000.pdf |
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| ACUVUE® OASYS Multifocal | Device | CONTROL Lens |
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| 30-minutes post lens insertion |
| Heterochromatic Contrast Threshold (HCT) | Using the same optical bench set-up described Glare Disability Threshold, to measure HCT, participants viewed the mid-wave (580 nm) grating target presented on presented on a short wave (460 nm) "sky-light background." The intensity of the background was adjusted, until the participant was no longer able to resolve the grating target. The log relative energy of the background needed to obscure the central target was recorded as HCT. Heterochromatic contrast thresholds are positive values, where higher values indicate better lens performance. The average threshold each lens type was reported. | 30-minutes post lens insertion |
| Two-Point Threshold (mm) With 403nm Filter | To create the two-point threshold stimulus, a single point- source like stimulus was spread into two distinct points of light, using a custom-built, collapsible light baffle. The two-point threshold was quantified as the minimum distance (mm) at which a participant could detect two distinct points of light, separated by a small black space. Measurements for this metric are positive. Smaller distances indicate better lens performance. The average distance for each lens type and period. | 30-minutes post lens insertion |
| Two-Point Threshold (mm) Without 403nm Filter | To create the two-point threshold stimulus, a single point- source like stimulus was spread into two distinct points of light, using a custom-built, collapsible light baffle. The two-point threshold was quantified as the minimum distance (mm) at which a participant could detect two distinct points of light, separated by a small black space. Measurements for this metric are positive. Smaller distances indicate better lens performance. The average distance for each lens type. | 30-minutes post lens insertion |
| Subject discontinued due to timing |
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| NOT COMPLETED |
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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 | Number | Participants |
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| OG001 | Senofilcon A (C3) | Subjects that wore senofilcon A (C3) lens in either the first or second period of the study. |
|
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| Primary | Halos Diameter (mm) | Halo diameter (mm) was quantified and measured using the same micrometer as for starbursts diameter (mm). The Halo diameter (mm) was measured each subject binocularly. Measurements for halo diameter are positive, where smaller values indicate better performance. The average diameter (mm) for each lens type. | All subjects fitted at least one study lens. | Posted | Mean | Standard Deviation | mm | 30-minutes post lens insertion |
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| Primary | Glare Disability Threshold | Glare disability threshold was collected binocularly for each subject. Subjects were exposed to a target stimulus for 2 seconds; before the measurement was taken the annulus was set to a level below that which would cause the target stimulus to be veiled. The experimenter would then adjust the intensity of the annulus until subjects could no longer see the target stimulus. Subjects would indicate this by pressing a buzzer. Glare disability thresholds take on positive values, where higher values indicate better lens performance. The average glare disability level (change in log relative energy) for each lens type was reported. | All subjects fitted at least one study lens. | Posted | Mean | Standard Deviation | log (change in log relative energy) | 30-minutes post lens insertion |
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| Secondary | Glare Discomfort (mm) | The Glare discomfort was evaluated by calculating the change in height of the palpebral fissure measured while the participant views the mid-wave central grating target, compared to the maximal squint during a 5-second Photostress exposure induced by a solid, 10-degree broadband field, which completely obscures the target (~10-deg diameter). Both eyes were recorded and averaged, to produce an average palpebral fissure height before and during the Photostress exposure. Glare discomfort can take on negative and positive values, where smaller values indicate better lens performance. The average glare discomfort (change in palpebral fissure height) for each lens type was reported. | All subjects fitted at least one study lens. | Posted | Mean | Standard Deviation | mm | 30-minutes post lens insertion |
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| Secondary | Heterochromatic Contrast Threshold (HCT) | Using the same optical bench set-up described Glare Disability Threshold, to measure HCT, participants viewed the mid-wave (580 nm) grating target presented on presented on a short wave (460 nm) "sky-light background." The intensity of the background was adjusted, until the participant was no longer able to resolve the grating target. The log relative energy of the background needed to obscure the central target was recorded as HCT. Heterochromatic contrast thresholds are positive values, where higher values indicate better lens performance. The average threshold each lens type was reported. | All subjects fitted at least one study lens. | Posted | Mean | Standard Deviation | log (change in log relative energy) | 30-minutes post lens insertion |
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|
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| Secondary | Two-Point Threshold (mm) With 403nm Filter | To create the two-point threshold stimulus, a single point- source like stimulus was spread into two distinct points of light, using a custom-built, collapsible light baffle. The two-point threshold was quantified as the minimum distance (mm) at which a participant could detect two distinct points of light, separated by a small black space. Measurements for this metric are positive. Smaller distances indicate better lens performance. The average distance for each lens type and period. | All subjects fitted at least one study lens. | Posted | Mean | Standard Deviation | mm | 30-minutes post lens insertion |
|
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| Secondary | Two-Point Threshold (mm) Without 403nm Filter | To create the two-point threshold stimulus, a single point- source like stimulus was spread into two distinct points of light, using a custom-built, collapsible light baffle. The two-point threshold was quantified as the minimum distance (mm) at which a participant could detect two distinct points of light, separated by a small black space. Measurements for this metric are positive. Smaller distances indicate better lens performance. The average distance for each lens type. | All subjects fitted at least one study lens. | Posted | Mean | Standard Deviation | mm | 30-minutes post lens insertion |
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| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Senofilcon A | Subjects that wore the senofilcon A lens during either period of the study. | 0 | 30 | 0 | 30 | 0 | 30 |
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| Period 2 |
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