CompletedNot Applicable

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

United States53 participantsStarted 2021-07-14

Plain-language 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.

Who can participate

Age range18 Years – 30 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Visual Photosensitivity Threshold (VPT)

Timeframe: at approximately 2-week follow-up

Trial details

NCT IDNCT04811079

SponsorJohnson & Johnson Vision Care, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-05-16

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