The Role of Spectral Filtering in a Spectrally Adjustable Ocular Photosensitivity Analyzer
Not Applicable
Completed
- Conditions
- Photosensitivity
- Interventions
- Other: 419 nm Spectacle FilterOther: 437 nm Spectacle FilterOther: 456 nm Spectacle FilterOther: 476 nm Spectacle FilterOther: 373 nm Spectacle Filter
- Registration Number
- NCT04811079
- Lead Sponsor
- Johnson & Johnson Vision Care, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 53
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Spectacle Filter Sequence 6 437 nm Spectacle Filter (476nm, 456nm, 373nm, 437nm, 419nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 6. Spectacle Filter Sequence 7 419 nm Spectacle Filter (373nm, 476nm, 419nm, 456nm, 437nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 7. Spectacle Filter Sequence 6 476 nm Spectacle Filter (476nm, 456nm, 373nm, 437nm, 419nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 6. Spectacle Filter Sequence 3 373 nm Spectacle Filter (456nm, 476nm, 437nm, 373nm, 419nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 3. Spectacle Filter Sequence 7 373 nm Spectacle Filter (373nm, 476nm, 419nm, 456nm, 437nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 7. Spectacle Filter Sequence 7 476 nm Spectacle Filter (373nm, 476nm, 419nm, 456nm, 437nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 7. Spectacle Filter Sequence 5 373 nm Spectacle Filter (373nm, 419nm, 476nm, 437nm, 456nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 5. Spectacle Filter Sequence 8 373 nm Spectacle Filter (419nm, 373nm, 437nm, 476nm, 456nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 8. Spectacle Filter Sequence 2 373 nm Spectacle Filter (437nm, 456nm, 419nm, 476nm, 373nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 2. Spectacle Filter Sequence 4 373 nm Spectacle Filter (476nm, 373nm, 456nm, 419nm, 437nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 4. Spectacle Filter Sequence 1 419 nm Spectacle Filter (419nm, 437nm, 373nm, 456nm, 476nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 1. Spectacle Filter Sequence 1 456 nm Spectacle Filter (419nm, 437nm, 373nm, 456nm, 476nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 1. Spectacle Filter Sequence 2 419 nm Spectacle Filter (437nm, 456nm, 419nm, 476nm, 373nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 2. Spectacle Filter Sequence 2 437 nm Spectacle Filter (437nm, 456nm, 419nm, 476nm, 373nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 2. Spectacle Filter Sequence 5 476 nm Spectacle Filter (373nm, 419nm, 476nm, 437nm, 456nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 5. Spectacle Filter Sequence 9 456 nm Spectacle Filter (437nm, 419nm, 456nm, 373nm, 476nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 9. Spectacle Filter Sequence 4 456 nm Spectacle Filter (476nm, 373nm, 456nm, 419nm, 437nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 4. Spectacle Filter Sequence 5 456 nm Spectacle Filter (373nm, 419nm, 476nm, 437nm, 456nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 5. Spectacle Filter Sequence 3 419 nm Spectacle Filter (456nm, 476nm, 437nm, 373nm, 419nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 3. Spectacle Filter Sequence 6 419 nm Spectacle Filter (476nm, 456nm, 373nm, 437nm, 419nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 6. Spectacle Filter Sequence 3 437 nm Spectacle Filter (456nm, 476nm, 437nm, 373nm, 419nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 3. Spectacle Filter Sequence 3 456 nm Spectacle Filter (456nm, 476nm, 437nm, 373nm, 419nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 3. Spectacle Filter Sequence 4 419 nm Spectacle Filter (476nm, 373nm, 456nm, 419nm, 437nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 4. Spectacle Filter Sequence 8 437 nm Spectacle Filter (419nm, 373nm, 437nm, 476nm, 456nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 8. Spectacle Filter Sequence 1 437 nm Spectacle Filter (419nm, 437nm, 373nm, 456nm, 476nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 1. Spectacle Filter Sequence 1 476 nm Spectacle Filter (419nm, 437nm, 373nm, 456nm, 476nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 1. Spectacle Filter Sequence 1 373 nm Spectacle Filter (419nm, 437nm, 373nm, 456nm, 476nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 1. Spectacle Filter Sequence 2 456 nm Spectacle Filter (437nm, 456nm, 419nm, 476nm, 373nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 2. Spectacle Filter Sequence 2 476 nm Spectacle Filter (437nm, 456nm, 419nm, 476nm, 373nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 2. Spectacle Filter Sequence 3 476 nm Spectacle Filter (456nm, 476nm, 437nm, 373nm, 419nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 3. Spectacle Filter Sequence 4 437 nm Spectacle Filter (476nm, 373nm, 456nm, 419nm, 437nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 4. Spectacle Filter Sequence 4 476 nm Spectacle Filter (476nm, 373nm, 456nm, 419nm, 437nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 4. Spectacle Filter Sequence 5 419 nm Spectacle Filter (373nm, 419nm, 476nm, 437nm, 456nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 5. Spectacle Filter Sequence 5 437 nm Spectacle Filter (373nm, 419nm, 476nm, 437nm, 456nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 5. Spectacle Filter Sequence 6 456 nm Spectacle Filter (476nm, 456nm, 373nm, 437nm, 419nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 6. Spectacle Filter Sequence 10 437 nm Spectacle Filter (456nm, 437nm, 476nm, 419nm, 373nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 10. Spectacle Filter Sequence 10 476 nm Spectacle Filter (456nm, 437nm, 476nm, 419nm, 373nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 10. Spectacle Filter Sequence 6 373 nm Spectacle Filter (476nm, 456nm, 373nm, 437nm, 419nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 6. Spectacle Filter Sequence 7 437 nm Spectacle Filter (373nm, 476nm, 419nm, 456nm, 437nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 7. Spectacle Filter Sequence 9 476 nm Spectacle Filter (437nm, 419nm, 456nm, 373nm, 476nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 9. Spectacle Filter Sequence 7 456 nm Spectacle Filter (373nm, 476nm, 419nm, 456nm, 437nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 7. Spectacle Filter Sequence 8 419 nm Spectacle Filter (419nm, 373nm, 437nm, 476nm, 456nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 8. Spectacle Filter Sequence 8 456 nm Spectacle Filter (419nm, 373nm, 437nm, 476nm, 456nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 8. Spectacle Filter Sequence 8 476 nm Spectacle Filter (419nm, 373nm, 437nm, 476nm, 456nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 8. Spectacle Filter Sequence 9 419 nm Spectacle Filter (437nm, 419nm, 456nm, 373nm, 476nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 9. Spectacle Filter Sequence 9 437 nm Spectacle Filter (437nm, 419nm, 456nm, 373nm, 476nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 9. Spectacle Filter Sequence 9 373 nm Spectacle Filter (437nm, 419nm, 456nm, 373nm, 476nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 9. Spectacle Filter Sequence 10 419 nm Spectacle Filter (456nm, 437nm, 476nm, 419nm, 373nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 10. Spectacle Filter Sequence 10 456 nm Spectacle Filter (456nm, 437nm, 476nm, 419nm, 373nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 10. Spectacle Filter Sequence 10 373 nm Spectacle Filter (456nm, 437nm, 476nm, 419nm, 373nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 10.
- Primary Outcome Measures
Name Time Method Visual Photosensitivity Threshold (VPT) at approximately 2-week follow-up 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Miami Health - Bascom Palmer Eye Institute
🇺🇸Coral Gables, Florida, United States
University of Miami Health - Bascom Palmer Eye Institute🇺🇸Coral Gables, Florida, United States