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

Johnson & Johnson (J&J) logo

Johnson & Johnson (J&J)

Status

Completed

Conditions

Photosensitivity

Treatments

Other: 476 nm Spectacle Filter
Other: 373 nm Spectacle Filter
Other: 419 nm Spectacle Filter
Other: 437 nm Spectacle Filter
Other: 456 nm Spectacle Filter

Study type

Interventional

Funder types

Industry

Identifiers

NCT04811079
CR-6402

Details and patient eligibility

About

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.

Enrollment

53 patients

Sex

All

Ages

18 to 30 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • Potential subjects must satisfy all of the following criteria to be enrolled in the study:

    1. The subject must read and sign the Informed Consent form.

    2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

    3. Healthy adult males or females age ≥18 and ≤30 years of age.

    4. Normal color vision as measured using the Ishihara 38-plate test.

    5. Normal stereopsis as measured by a suitable test.

    6. 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.

    7. The subject's distance refractive sphere must be between -2.00 and +2.00 D in each eye.

    8. The subject's distance refractive cylinder must be ≤ 1.50 D in each eye.

    9. The subject must have unaided distance Snellen visual acuity of 20/200 or better for each eye.

    10. 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:

    1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
    2. History of refractive surgery or other ocular surgery.
    3. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
    4. Subjects that participated in the pilot study CR-6318.
    5. Systemic conditions or the use of medications that the investigator believes will contraindicate participation in this study.
    6. Abnormal Level 3 neuro-ophthalmology exam including crystalline lens clarity Grade 3 or worse (Lens Opacities Classification System).
    7. 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

53 participants in 10 patient groups

Spectacle Filter Sequence 1
Experimental group
Description:
(419nm, 437nm, 373nm, 456nm, 476nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 1.
Treatment:
Other: 456 nm Spectacle Filter
Other: 437 nm Spectacle Filter
Other: 373 nm Spectacle Filter
Other: 419 nm Spectacle Filter
Other: 476 nm Spectacle Filter
Spectacle Filter Sequence 2
Experimental group
Description:
(437nm, 456nm, 419nm, 476nm, 373nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 2.
Treatment:
Other: 456 nm Spectacle Filter
Other: 437 nm Spectacle Filter
Other: 373 nm Spectacle Filter
Other: 419 nm Spectacle Filter
Other: 476 nm Spectacle Filter
Spectacle Filter Sequence 3
Experimental group
Description:
(456nm, 476nm, 437nm, 373nm, 419nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 3.
Treatment:
Other: 456 nm Spectacle Filter
Other: 437 nm Spectacle Filter
Other: 373 nm Spectacle Filter
Other: 419 nm Spectacle Filter
Other: 476 nm Spectacle Filter
Spectacle Filter Sequence 4
Experimental group
Description:
(476nm, 373nm, 456nm, 419nm, 437nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 4.
Treatment:
Other: 456 nm Spectacle Filter
Other: 437 nm Spectacle Filter
Other: 373 nm Spectacle Filter
Other: 419 nm Spectacle Filter
Other: 476 nm Spectacle Filter
Spectacle Filter Sequence 5
Experimental group
Description:
(373nm, 419nm, 476nm, 437nm, 456nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 5.
Treatment:
Other: 456 nm Spectacle Filter
Other: 437 nm Spectacle Filter
Other: 373 nm Spectacle Filter
Other: 419 nm Spectacle Filter
Other: 476 nm Spectacle Filter
Spectacle Filter Sequence 6
Experimental group
Description:
(476nm, 456nm, 373nm, 437nm, 419nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 6.
Treatment:
Other: 456 nm Spectacle Filter
Other: 437 nm Spectacle Filter
Other: 373 nm Spectacle Filter
Other: 419 nm Spectacle Filter
Other: 476 nm Spectacle Filter
Spectacle Filter Sequence 7
Experimental group
Description:
(373nm, 476nm, 419nm, 456nm, 437nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 7.
Treatment:
Other: 456 nm Spectacle Filter
Other: 437 nm Spectacle Filter
Other: 373 nm Spectacle Filter
Other: 419 nm Spectacle Filter
Other: 476 nm Spectacle Filter
Spectacle Filter Sequence 8
Experimental group
Description:
(419nm, 373nm, 437nm, 476nm, 456nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 8.
Treatment:
Other: 456 nm Spectacle Filter
Other: 437 nm Spectacle Filter
Other: 373 nm Spectacle Filter
Other: 419 nm Spectacle Filter
Other: 476 nm Spectacle Filter
Spectacle Filter Sequence 9
Experimental group
Description:
(437nm, 419nm, 456nm, 373nm, 476nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 9.
Treatment:
Other: 456 nm Spectacle Filter
Other: 437 nm Spectacle Filter
Other: 373 nm Spectacle Filter
Other: 419 nm Spectacle Filter
Other: 476 nm Spectacle Filter
Spectacle Filter Sequence 10
Experimental group
Description:
(456nm, 437nm, 476nm, 419nm, 373nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 10.
Treatment:
Other: 456 nm Spectacle Filter
Other: 437 nm Spectacle Filter
Other: 373 nm Spectacle Filter
Other: 419 nm Spectacle Filter
Other: 476 nm Spectacle Filter

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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