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This is a single visit, single site, brand-masked, non-dispensing, 2×2 bilateral crossover study. Each subject will be bilaterally fitted with one of the two test articles in each of the study periods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test/Control | Experimental | Eligible Subjects aged 18 to 39 years (inclusive) who are habitual soft contact lens wearers will be randomized into sequence, Test/Control |
|
| Control/Test | Experimental | Eligible Subjects aged 18 to 39 years (inclusive) who are habitual soft contact lens wearers will be randomized into sequence, Control/Test. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JJVC Investigational Contact Lens | Device | TEST |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Distance Binocular Visual Acuity (logMAR) | Visual acuity on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4 meters) under high luminance high contrast, high luminance low contrast and low luminance high contrast with distance goggles using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. 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 value of 0.0 is equivalent to 20/20 Snellen vision. | 20- Minutes Post-Lens Fitting |
| Near BinocularVisual Acuity (logMAR) | Visual acuity on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at near (40 cm) under High luminance low contrast and low luminance high contrast with distance goggles using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. 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 value of 0.0 is equivalent to 20/20 Snellen vision. | 20- Minutes Post-Lens Fitting |
| Quantitative Visual Acuity | Quantitative Visual Acuity (qVA) was measured at distance (4 meter) under low room illumination (4 lux), low luminance, high contrast conditions in the right eye only and in both eyes using AST Sentio vision Testing System. During testing 25 triplets of test letters were displayed on a large stationary monitor (118 CM), the operator recorded the patient's responses using the remote (Android Tablet). After a testing session had been completed the software calculated the VA threshold. VA threshold was defined as the logMAR stimulus size at which the expected probability of correct letter identification is 66%. when both eyes are measured. The average median VA threshold was reported for each lens. Lower values indicate better vision. | 20- Minutes Post-Lens Fitting |
| Area Under Contrast Sensitivity Function Curve | Area under the log Curve was measured at 1.5, 3, 6, 12 and 18 cycles per degree (cpd) in the right eye only and in both eyes using AST Sentio vision Testing System. During testing 25 triplets of test letters were displayed on a large stationary monitor (118 CM), the operator recorded the patient's responses using the remote (Android Tablet). After a testing session had been completed the software calculated the Area under the log contrast sensitivity function from 1.5 cpd to 18 cpd. The average area under the log curve was reported for each lens. Higher values indicate better vision. Number of eyes is 50 when both eyes are measured. |
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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
Appear able and willing to adhere to the instructions set forth in this clinical protocol.
Subjects between 18 and 39 (inclusive) years of age at the time of screening
Be a current soft contact lens wearer in both eyes with a minimum of 6 hours/day and 5 days/week over the last month by self-report.
The subject must be willing to be photographed and/or video-taped.
The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 D to -5.00 D (inclusive) in each eye
The subject's refractive cylinder must be less than or equal to 0.75 D (inclusive) in each eye
Have spherical best corrected visual acuity of 20/25 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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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VRC-East | Jacksonville | Florida | 32256 | 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 28 subjects were enrolled into this study. Of those enrolled 25 were dispensed study lenses and completed the study, while 3 subjects failed to meet all eligibility criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test/Control | Subjects randomized to this sequence received the Test lens during the first period and then received the Control lens during the second period. |
| FG001 | Control/Test | Subjects randomized to this sequence received the Control lens during the first period and then received the Test lens during the second period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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All subjects dispensed a study lens.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | All subjects who were dispensed a 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 | Distance Binocular Visual Acuity (logMAR) | Visual acuity on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4 meters) under high luminance high contrast, high luminance low contrast and low luminance high contrast with distance goggles using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. 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 value of 0.0 is equivalent to 20/20 Snellen vision. | All subjects who had successfully completed all visits and did not substantially deviate from the protocol. | Posted | Mean | Standard Deviation | logMAR | 20- Minutes Post-Lens Fitting |
|
Throughout the duration of the study. Approximately 1 day per subject.
All subjects dispensed at least 1 study lens.
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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 | Subjects that wore the Test lens in either the first or second period of the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Meredith Bishop OD, MS, FAAO | Johnson & Johnson Vision Care | 1-800-843-2020 | mbishop4@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 29, 2020 | Feb 25, 2021 | Prot_SAP_000.pdf |
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| 1-DAY ACUVUE® DEFINE® Radiant Sweet™ |
| Device |
CONTROL |
|
| 20- Minutes Post-Lens Fitting |
| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Control | Subjects that wore the Control lens in either the first or second period of the study. |
|
|
| Primary | Near BinocularVisual Acuity (logMAR) | Visual acuity on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at near (40 cm) under High luminance low contrast and low luminance high contrast with distance goggles using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. 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 value of 0.0 is equivalent to 20/20 Snellen vision. | All subjects who had successfully completed all visits and did not substantially deviate from the protocol. | Posted | Mean | Standard Deviation | logMAR | 20- Minutes Post-Lens Fitting |
|
|
|
| Primary | Quantitative Visual Acuity | Quantitative Visual Acuity (qVA) was measured at distance (4 meter) under low room illumination (4 lux), low luminance, high contrast conditions in the right eye only and in both eyes using AST Sentio vision Testing System. During testing 25 triplets of test letters were displayed on a large stationary monitor (118 CM), the operator recorded the patient's responses using the remote (Android Tablet). After a testing session had been completed the software calculated the VA threshold. VA threshold was defined as the logMAR stimulus size at which the expected probability of correct letter identification is 66%. when both eyes are measured. The average median VA threshold was reported for each lens. Lower values indicate better vision. | All subjects who had successfully completed all visits and did not substantially deviate from the protocol. | Posted | Mean | Standard Deviation | logMAR | 20- Minutes Post-Lens Fitting | eyes | eyes |
|
|
|
| Primary | Area Under Contrast Sensitivity Function Curve | Area under the log Curve was measured at 1.5, 3, 6, 12 and 18 cycles per degree (cpd) in the right eye only and in both eyes using AST Sentio vision Testing System. During testing 25 triplets of test letters were displayed on a large stationary monitor (118 CM), the operator recorded the patient's responses using the remote (Android Tablet). After a testing session had been completed the software calculated the Area under the log contrast sensitivity function from 1.5 cpd to 18 cpd. The average area under the log curve was reported for each lens. Higher values indicate better vision. Number of eyes is 50 when both eyes are measured. | All subjects who had successfully completed all visits and did not substantially deviate from the protocol. | Posted | Mean | Standard Deviation | log contrast sensitivity*cpd | 20- Minutes Post-Lens Fitting | eyes | eyes |
|
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| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Control | Subjects that wore the Control lens in either the first or second period of the study. | 0 | 25 | 0 | 25 | 0 | 25 |
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| Both Eyes |
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| Both Eyes |
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