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PhotosensitivityNCT04811079

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

A study testing 419 nm Spectacle Filter, 437 nm Spectacle Filter and 456 nm Spectacle Filter in people with Photosensitivity, run by Johnson & Johnson Vision Care, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for
Photosensitivity
What is being tested?
419 nm Spectacle Filter, 437 nm Spectacle Filter and 456 nm Spectacle Filter
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
1 siteUnited States
Study dates
14 Jul 2021to 16 May 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
Show all 11Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Miami Health - Bascom Palmer Eye Institute

    Coral Gables, Florida, 33146

Other trials in United States

About this study

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.

Being tested
419 nm Spectacle Filter, 437 nm Spectacle Filter, 456 nm Spectacle Filter, 476 nm Spectacle Filter, 373 nm Spectacle Filter
Medical subject headings
Photosensitivity Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 419 nm Spectacle FilterOther

    TEST

  • 437 nm Spectacle FilterOther

    TEST

  • 456 nm Spectacle FilterOther

    TEST

  • 476 nm Spectacle FilterOther

    TEST

  • 373 nm Spectacle FilterOther

    CONTROL

Study groups in NCT04811079
Study groupRoleWhat they receive
Spectacle Filter Sequence 1Experimental(419nm, 437nm, 373nm, 456nm, 476nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 1.
Receives: 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
Spectacle Filter Sequence 2Experimental(437nm, 456nm, 419nm, 476nm, 373nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 2.
Receives: 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
Spectacle Filter Sequence 3Experimental(456nm, 476nm, 437nm, 373nm, 419nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 3.
Receives: 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
Spectacle Filter Sequence 4Experimental(476nm, 373nm, 456nm, 419nm, 437nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 4.
Receives: 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
Spectacle Filter Sequence 5Experimental(373nm, 419nm, 476nm, 437nm, 456nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 5.
Receives: 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
Spectacle Filter Sequence 6Experimental(476nm, 456nm, 373nm, 437nm, 419nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 6.
Receives: 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
Spectacle Filter Sequence 7Experimental(373nm, 476nm, 419nm, 456nm, 437nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 7.
Receives: 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
Spectacle Filter Sequence 8Experimental(419nm, 373nm, 437nm, 476nm, 456nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 8.
Receives: 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
Spectacle Filter Sequence 9Experimental(437nm, 419nm, 456nm, 373nm, 476nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 9.
Receives: 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
Spectacle Filter Sequence 10Experimental(456nm, 437nm, 476nm, 419nm, 373nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 10.
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: at approximately 2-week follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2021
  2. Study start14 Jul 2021
  3. Primary completion16 May 2022
  4. Study completion16 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04811079
Sponsor's protocol ID
CR-6402
Status last verified
Apr 2025
First submitted
22 Mar 2021
Last updated
25 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A study testing 419 nm Spectacle Filter, 437 nm Spectacle Filter and 456 nm Spectacle Filter in people with Photosensitivity, run by Johnson & Johnson Vision Care, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Photosensitivity Threshold (VPT) (time frame: at approximately 2-week follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04811079.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.

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