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This will be a split-plot design, randomized, parallel, double-masked feasibility study to evaluate the role of a test lens on contrast sensitivity with and without glare.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEST/CONTROL/Photopic CSF | Experimental | Eligible subjects who are habitual wearers of silicone hydrogel contact lenses will be randomized to the photopic condition and randomized contralaterally to the TEST/CONTROL lenses. |
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| TEST/CONTROL/Mesopic CSF | Experimental | Eligible subjects who are habitual wearers of silicone hydrogel contact lenses will be randomized to the mesopic condition and randomized contralaterally to the TEST/CONTROL lenses. |
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| CONTROL/TEST/Photopic CSF | Experimental | Eligible subjects who are habitual wearers of silicone hydrogel contact lenses will be randomized to the photopic condition and randomized contralaterally to the CONTROL/TEST lenses. |
|
| CONTROL/TEST/Mesopic CSF | Experimental | Eligible subjects who are habitual wearers of silicone hydrogel contact lenses will be randomized to the mesopic condition and randomized contralaterally to the CONTROL/TEST lenses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test Lens | Device | ACUVUE OASYS MAX 1-Day with TearStable Technology and OptiBlue Light Filter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve of Photopic Contrast Sensitivity Function Under Bright Light Conditions (∼120 cd/m2) With a Broadband Glare Source | Photopic contrast sensitivity was measured under bright light conditions (~120 cd/m2) with a broadband glare source at five spatial frequencies (1.6, 3.2, 8, 16 and 24 cpd) using the University of Georgia system. The area under the log contrast sensitivity function (AULCSF) was derived by first calculating the logarithm of contrast sensitivity as logCS = log10(contrast sensitivity), and then AULCSF was calculated using logCS and the log (base 10) of each spatial frequency based on the trapezoidal rule per eye per subject. The AULCSF was computed by trapezoidal integration of the logarithm of the contrast sensitivity (vertical axis) as a function of the logarithm of spatial frequency (horizontal axis). The unit of the horizontal axis is log(cpd) since spatial frequency is in the unit of cycles per degree (cpd). Although, sensitivity is a unitless parameter, to aid interpretation, the units of AULCSF are described as log(sensitivity)*log(cpd). | Up to 2 hours post-fitting |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve of Mesopic Contrast Sensitivity Under Dim Light Conditions (∼3 cd/m2) With a Broadband Glare Source. | Mesopic contrast sensitivity was measured under dim light conditions (~3 cd/m2) with a broadband glare source at five spatial frequencies (1.6, 3.2, 8, 16 and 24 cpd) using the University of Georgia system. The area under the log contrast sensitivity function (AULCSF) was derived by first calculating the logarithm of contrast sensitivity as logCS = log10(contrast sensitivity), and then AULCSF was calculated using logCS and the log (base 10) of each spatial frequency based on the trapezoidal rule per eye per subject. The AULCSF was computed by trapezoidal integration of the logarithm of the contrast sensitivity (vertical axis) as a function of the logarithm of spatial frequency (horizontal axis). The unit of the horizontal axis is log(cpd) since spatial frequency is in the unit of cycles per degree (cpd). Although, sensitivity is a unitless parameter, to aid interpretation, the units of AULCSF are described as log(sensitivity)*log(cpd). |
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Inclusion Criteria:
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
The subject must:
Exclusion Criteria:
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
The subject must not:
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42319244 | Derived | Hammond BR, Buch JR, Martin P, Xu J, Renzi-Hammond LM. Effects of HEV-Filtering in a Soft Contact Lens on Contrast Sensitivity With and Without Veiling Glare. Eye Contact Lens. 2026 Jun 22. doi: 10.1097/ICL.0000000000001296. Online ahead of print. |
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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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This was a split-plot design with two parallel arms consisting of two randomized lighting conditions (photopic and mesopic). Within each parallel arm, subjects were further randomized in a contralateral fashion to the Test and Control lenses. A total of 40 subjects were enrolled and completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Photopic: OD: Test (Senofilcon A C3) / OS: Control (Senofilcon A C3) | Subjects randomized to this condition arm and lens sequence received the Test lens on the right eye and received the Control lens on the left eye under the photopic condition. |
| FG001 | Photopic: OD: Control (Senofilcon A C3) / OS: Test (Senofilcon A C3) | Subjects randomized to this condition arm and lens sequence received the Control lens on the right eye and received the Test lens on the left eye under the photopic condition. |
| FG002 | Mesopic: OD: Test (Senofilcon A C3) / OS: Control (Senofilcon A C3) | Subjects randomized to this condition arm and lens sequence received the Test lens on the right eye and received the Control lens on the left eye under the mesopic condition. |
| FG003 | Mesopic: OD: Control (Senofilcon A C3) / OS: Test (Senofilcon A C3) | Subjects randomized to this condition arm and lens sequence received the Control lens on the right eye and received the Test lens on the left eye under the mesopic condition |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All subjects administered a study lens.
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| ID | Title | Description |
|---|---|---|
| BG000 | Photopic | Subjects assigned bright light conditions (~120 cd/m2). |
| BG001 | Mesopic | Subjects assigned dim light conditions (~3cd/m2). |
| 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 | Area Under the Curve of Photopic Contrast Sensitivity Function Under Bright Light Conditions (∼120 cd/m2) With a Broadband Glare Source | Photopic contrast sensitivity was measured under bright light conditions (~120 cd/m2) with a broadband glare source at five spatial frequencies (1.6, 3.2, 8, 16 and 24 cpd) using the University of Georgia system. The area under the log contrast sensitivity function (AULCSF) was derived by first calculating the logarithm of contrast sensitivity as logCS = log10(contrast sensitivity), and then AULCSF was calculated using logCS and the log (base 10) of each spatial frequency based on the trapezoidal rule per eye per subject. The AULCSF was computed by trapezoidal integration of the logarithm of the contrast sensitivity (vertical axis) as a function of the logarithm of spatial frequency (horizontal axis). The unit of the horizontal axis is log(cpd) since spatial frequency is in the unit of cycles per degree (cpd). Although, sensitivity is a unitless parameter, to aid interpretation, the units of AULCSF are described as log(sensitivity)*log(cpd). | All randomized subjects regardless of actual treatment and subsequent withdrawal from study or deviation from protocol. | Posted | Mean | Standard Deviation | log(sensitivity)*log(cpd) | Up to 2 hours post-fitting | eyes | eyes |
Throughout the duration of the study. Approximately three hours 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 (Senofilcon A C3) | Subjects that wore the Test lens in either eye during the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John R Buch | Johnson & Johnson Vision Care, Inc. (JJVC) | 1-800-843-2020 | jbuch@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 | Nov 2, 2022 | Nov 20, 2023 | Prot_SAP_000.pdf |
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| Control Lens | Device | ACUVUE OASYS 1-Day with HydraLuxe Technology |
|
| Up to 2 hours post-fitting |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Region of Enrollment | Number | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Test (Senofilcon A C3) | Subject eyes that wore the Test lens during the study. |
| OG001 | Control (Senofilcon A C3) | Subject eyes that wore the Control lens during the study. |
|
|
| Secondary | Area Under the Curve of Mesopic Contrast Sensitivity Under Dim Light Conditions (∼3 cd/m2) With a Broadband Glare Source. | Mesopic contrast sensitivity was measured under dim light conditions (~3 cd/m2) with a broadband glare source at five spatial frequencies (1.6, 3.2, 8, 16 and 24 cpd) using the University of Georgia system. The area under the log contrast sensitivity function (AULCSF) was derived by first calculating the logarithm of contrast sensitivity as logCS = log10(contrast sensitivity), and then AULCSF was calculated using logCS and the log (base 10) of each spatial frequency based on the trapezoidal rule per eye per subject. The AULCSF was computed by trapezoidal integration of the logarithm of the contrast sensitivity (vertical axis) as a function of the logarithm of spatial frequency (horizontal axis). The unit of the horizontal axis is log(cpd) since spatial frequency is in the unit of cycles per degree (cpd). Although, sensitivity is a unitless parameter, to aid interpretation, the units of AULCSF are described as log(sensitivity)*log(cpd). | All randomized subjects regardless of actual treatment and subsequent withdrawal from study or deviation from protocol. | Posted | Mean | Standard Deviation | log(sensitivity)*log(cpd) | Up to 2 hours post-fitting | eyes | eyes |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Control (Senofilcon A C3) | Subjects that wore the Control lens in either eye during the study. | 0 | 40 | 0 | 40 | 0 | 40 |
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