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This is a 6-visit, single-center, non-dispensing, randomized, single-masked, 5×5 crossover study. Subjects will participate in 6 scheduled over the duration of approximately 10.5 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spectacle Filter Sequence 1 | Experimental | (419nm, 437nm, 373nm, 456nm, 476nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 1. |
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| Spectacle Filter Sequence 2 | Experimental | (437nm, 456nm, 419nm, 476nm, 373nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 2. |
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| Spectacle Filter Sequence 3 | Experimental | (456nm, 476nm, 437nm, 373nm, 419nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 3. |
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| Spectacle Filter Sequence 4 | Experimental | (476nm, 373nm, 456nm, 419nm, 437nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 4. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 419 nm Spectacle Filter | Other | TEST |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Photosensitivity Threshold (VPT) | VPT will measured via the SAOPA instrument. VPT is the point at which a sensation of pain or discomfort occurs when the intensity of light is gradually increased from a low level. Subject's discomfort responses will be indicated via a button press. Testing is complete when 10 response reversals are acquired. | at approximately 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 and sign the Informed Consent form.
The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
Healthy adult males or females age ≥18 and ≤30 years of age.
Normal color vision as measured using the Ishihara 38-plate test.
Normal stereopsis as measured by a suitable test.
Auto-refraction must show a spherical component of -2.00 through +2.00 D, and a cylindrical component of 0.00 through 1.50 D.
The subject's distance refractive sphere must be between -2.00 and +2.00 D in each eye.
The subject's distance refractive cylinder must be ≤ 1.50 D in each eye.
The subject must have unaided distance Snellen visual acuity of 20/200 or better for each eye.
The subject must have best corrected distance Snellen visual acuity of 20/25 or better for 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 Miami Health - Bascom Palmer Eye Institute | Coral Gables | Florida | 33146 | 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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| Spectacle Filter Sequence 5 | Experimental | (373nm, 419nm, 476nm, 437nm, 456nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 5. |
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| Spectacle Filter Sequence 6 | Experimental | (476nm, 456nm, 373nm, 437nm, 419nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 6. |
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| Spectacle Filter Sequence 7 | Experimental | (373nm, 476nm, 419nm, 456nm, 437nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 7. |
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| Spectacle Filter Sequence 8 | Experimental | (419nm, 373nm, 437nm, 476nm, 456nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 8. |
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| Spectacle Filter Sequence 9 | Experimental | (437nm, 419nm, 456nm, 373nm, 476nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 9. |
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| Spectacle Filter Sequence 10 | Experimental | (456nm, 437nm, 476nm, 419nm, 373nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 10. |
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| 437 nm Spectacle Filter | Other | TEST |
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| 456 nm Spectacle Filter | Other | TEST |
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| 476 nm Spectacle Filter | Other | TEST |
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| 373 nm Spectacle Filter | Other | CONTROL |
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| ID | Term |
|---|---|
| D010787 | Photosensitivity Disorders |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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