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.

Study Overview

• Status: Completed
• Conditions: Photosensitivity
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Coral Gables, Florida, United States, 33146
      • University of Miami Health - Bascom Palmer Eye Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

10

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.
• Investigators: Study Director: Johnson & Johnson Vision Care, Inc. Clinical Trial, Johnson & Johnson Vision Care, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2021
• Primary Completion (Actual): May 16, 2022
• Study Completion (Actual): May 16, 2022

Study Registration Dates

• First Submitted: March 22, 2021
• First Submitted That Met QC Criteria: March 22, 2021
• First Posted (Actual): March 23, 2021

Study Record Updates

• Last Update Posted (Actual): April 25, 2025
• Last Update Submitted That Met QC Criteria: April 24, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Skin Diseases; Vision Disorders; Sensation Disorders; Photophobia; Photosensitivity Disorders
• Other Study ID Numbers: CR-6402

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No