The Role of Spectral Filtering in a Spectrally Adjustable Ocular Photosensitivity Analyzer

Study Overview
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Brief Summary
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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.

Official Title
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The Role of Spectral Filtering in a Spectrally Adjustable Ocular Photosensitivity Analyzer

Conditions
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Photosensitivity

Intervention / Treatment
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* Other: 419 nm Spectacle Filter
* Other: 437 nm Spectacle Filter
* Other: 456 nm Spectacle Filter
* Other: 476 nm Spectacle Filter
* Other: 373 nm Spectacle Filter


Participation Criteria
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Eligibility Criteria
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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: Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued). History of refractive surgery or other ocular surgery. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician). Subjects that participated in the pilot study CR-6318. Systemic conditions or the use of medications that the investigator believes will contraindicate participation in this study. Abnormal Level 3 neuro-ophthalmology exam including crystalline lens clarity Grade 3 or worse (Lens Opacities Classification System). Any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA Slit Lamp Classification Scale.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spectacle Filter Sequence 1<br>(419nm, 437nm, 373nm, 456nm, 476nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 1. | Other: 419 nm Spectacle Filter<br>* TEST<br>Other: 437 nm Spectacle Filter<br>* TEST<br>Other: 456 nm Spectacle Filter<br>* TEST<br>Other: 476 nm Spectacle Filter<br>* TEST<br>Other: 373 nm Spectacle Filter<br>* CONTROL<br>|
| Experimental: Spectacle Filter Sequence 2<br>(437nm, 456nm, 419nm, 476nm, 373nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 2. | Other: 419 nm Spectacle Filter<br>* TEST<br>Other: 437 nm Spectacle Filter<br>* TEST<br>Other: 456 nm Spectacle Filter<br>* TEST<br>Other: 476 nm Spectacle Filter<br>* TEST<br>Other: 373 nm Spectacle Filter<br>* CONTROL<br>|
| Experimental: Spectacle Filter Sequence 3<br>(456nm, 476nm, 437nm, 373nm, 419nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 3. | Other: 419 nm Spectacle Filter<br>* TEST<br>Other: 437 nm Spectacle Filter<br>* TEST<br>Other: 456 nm Spectacle Filter<br>* TEST<br>Other: 476 nm Spectacle Filter<br>* TEST<br>Other: 373 nm Spectacle Filter<br>* CONTROL<br>|
| Experimental: Spectacle Filter Sequence 4<br>(476nm, 373nm, 456nm, 419nm, 437nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 4. | Other: 419 nm Spectacle Filter<br>* TEST<br>Other: 437 nm Spectacle Filter<br>* TEST<br>Other: 456 nm Spectacle Filter<br>* TEST<br>Other: 476 nm Spectacle Filter<br>* TEST<br>Other: 373 nm Spectacle Filter<br>* CONTROL<br>|
| Experimental: Spectacle Filter Sequence 5<br>(373nm, 419nm, 476nm, 437nm, 456nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 5. | Other: 419 nm Spectacle Filter<br>* TEST<br>Other: 437 nm Spectacle Filter<br>* TEST<br>Other: 456 nm Spectacle Filter<br>* TEST<br>Other: 476 nm Spectacle Filter<br>* TEST<br>Other: 373 nm Spectacle Filter<br>* CONTROL<br>|
| Experimental: Spectacle Filter Sequence 6<br>(476nm, 456nm, 373nm, 437nm, 419nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 6. | Other: 419 nm Spectacle Filter<br>* TEST<br>Other: 437 nm Spectacle Filter<br>* TEST<br>Other: 456 nm Spectacle Filter<br>* TEST<br>Other: 476 nm Spectacle Filter<br>* TEST<br>Other: 373 nm Spectacle Filter<br>* CONTROL<br>|
| Experimental: Spectacle Filter Sequence 7<br>(373nm, 476nm, 419nm, 456nm, 437nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 7. | Other: 419 nm Spectacle Filter<br>* TEST<br>Other: 437 nm Spectacle Filter<br>* TEST<br>Other: 456 nm Spectacle Filter<br>* TEST<br>Other: 476 nm Spectacle Filter<br>* TEST<br>Other: 373 nm Spectacle Filter<br>* CONTROL<br>|
| Experimental: Spectacle Filter Sequence 8<br>(419nm, 373nm, 437nm, 476nm, 456nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 8. | Other: 419 nm Spectacle Filter<br>* TEST<br>Other: 437 nm Spectacle Filter<br>* TEST<br>Other: 456 nm Spectacle Filter<br>* TEST<br>Other: 476 nm Spectacle Filter<br>* TEST<br>Other: 373 nm Spectacle Filter<br>* CONTROL<br>|
| Experimental: Spectacle Filter Sequence 9<br>(437nm, 419nm, 456nm, 373nm, 476nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 9. | Other: 419 nm Spectacle Filter<br>* TEST<br>Other: 437 nm Spectacle Filter<br>* TEST<br>Other: 456 nm Spectacle Filter<br>* TEST<br>Other: 476 nm Spectacle Filter<br>* TEST<br>Other: 373 nm Spectacle Filter<br>* CONTROL<br>|
| Experimental: Spectacle Filter Sequence 10<br>(456nm, 437nm, 476nm, 419nm, 373nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 10. | Other: 419 nm Spectacle Filter<br>* TEST<br>Other: 437 nm Spectacle Filter<br>* TEST<br>Other: 456 nm Spectacle Filter<br>* TEST<br>Other: 476 nm Spectacle Filter<br>* TEST<br>Other: 373 nm Spectacle Filter<br>* CONTROL<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |