ClinicalTrials.gg
CompletedNCT04811079Updated Apr 25, 2025

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

An interventional study of 419 nm Spectacle Filter and 437 nm Spectacle Filter in Photosensitivity, sponsored by Johnson & Johnson Vision Care, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-25.

Sponsored by Johnson & Johnson Vision Care, Inc. (part of Johnson & Johnson) · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
53
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 12 studies in Photosensitivity Disorders with a site in United States — 2 open to participants now, 2 under way, none of them phase 3. Photosensitivity Disorders · United States.

Started
2021
the only one that year
No phase
3 of 12
1 open now
Registered
10th of 12
by date
Lead sponsor
1 of 12
Johnson & Johnson Vision Care, Inc.

Among the 12 studies in Photosensitivity Disorders with a site in United States, this one is the only one that started in 2021, is one of 3 with no phase, and was the 10th registered.

By phase

12 studies; the count open now beside each. This study's row is marked.

No phasethis study3 · 1 open
Observational3 · 0 open
Phase 23 · 0 open
Phase 1/22 · 0 open
Phase 11 · 1 open

By the year they started

First in 2005; this study’s year is marked. 1 started in 2021.

Size and results

Median enrollment 24 across the 9 interventional studies, 537 across the 3 observational. Of the 9 that completed or were terminated, 3 (33%) have results posted.

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02

Study 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.

03

Conditions studied

  • Photosensitivity
04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
53 participants (actual)

Study arms

  • 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 · Other: 437 nm Spectacle Filter · Other: 456 nm Spectacle Filter · Other: 476 nm Spectacle Filter · Other: 373 nm Spectacle Filter

  • 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 · Other: 437 nm Spectacle Filter · Other: 456 nm Spectacle Filter · Other: 476 nm Spectacle Filter · Other: 373 nm Spectacle Filter

  • 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 · Other: 437 nm Spectacle Filter · Other: 456 nm Spectacle Filter · Other: 476 nm Spectacle Filter · Other: 373 nm Spectacle Filter

  • 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 · Other: 437 nm Spectacle Filter · Other: 456 nm Spectacle Filter · Other: 476 nm Spectacle Filter · Other: 373 nm Spectacle Filter

  • 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 · Other: 437 nm Spectacle Filter · Other: 456 nm Spectacle Filter · Other: 476 nm Spectacle Filter · Other: 373 nm Spectacle Filter

  • 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 · Other: 437 nm Spectacle Filter · Other: 456 nm Spectacle Filter · Other: 476 nm Spectacle Filter · Other: 373 nm Spectacle Filter

  • 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 · Other: 437 nm Spectacle Filter · Other: 456 nm Spectacle Filter · Other: 476 nm Spectacle Filter · Other: 373 nm Spectacle Filter

  • 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 · Other: 437 nm Spectacle Filter · Other: 456 nm Spectacle Filter · Other: 476 nm Spectacle Filter · Other: 373 nm Spectacle Filter

  • 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 · Other: 437 nm Spectacle Filter · Other: 456 nm Spectacle Filter · Other: 476 nm Spectacle Filter · Other: 373 nm Spectacle Filter

  • 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 · Other: 437 nm Spectacle Filter · Other: 456 nm Spectacle Filter · Other: 476 nm Spectacle Filter · Other: 373 nm Spectacle Filter

Interventions

  • Other419 nm Spectacle Filter

    TEST

  • Other437 nm Spectacle Filter

    TEST

  • Other456 nm Spectacle Filter

    TEST

  • Other476 nm Spectacle Filter

    TEST

  • Other373 nm Spectacle Filter

    CONTROL

06

What researchers measure

Primary outcomes

  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.

    Time frame: at approximately 2-week follow-up

07

Study locations

1 site
  • University of Miami Health - Bascom Palmer Eye Institute
    Coral Gables, Florida 33146, United States
08

References and documents

Individual participant data

Plan to share: 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

Data sharing details ↗ · yoda.yale.edu

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2021 to primary completion in May 2022, 10 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 22, 2021
First posted
Mar 23, 2021
StartActual
Jul 14, 2021
Primary completionActual
May 16, 2022
CompletionActual
May 16, 2022
Last update
Apr 25, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04811079
Responsible party
Sponsor
First posted
Mar 23, 2021
Start date
Jul 14, 2021
Primary completion
May 16, 2022
Completion
May 16, 2022
Last update
Apr 25, 2025

Study contacts

Johnson & Johnson Vision Care, Inc. Clinical Trial
study director · Johnson & Johnson Vision Care, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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