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OpenTrials
Completed

NCT Number: NCT04811079

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

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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Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami Health - Bascom Palmer Eye Institute

Coral Gables, Florida, 33146, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

419 nm Spectacle Filter

Other

TEST

437 nm Spectacle Filter

Other

TEST

456 nm Spectacle Filter

Other

TEST

476 nm Spectacle Filter

Other

TEST

373 nm Spectacle Filter

Other

CONTROL

Primary outcomes

  1. Visual Photosensitivity Threshold (VPT)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Vision Care, Inc.

Industry

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 23, 2021
Registry last updated
Apr 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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