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

April 24, 2025 updated by: Johnson & Johnson Vision Care, Inc.
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
53

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
at approximately 2-week follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johnson & Johnson Vision Care, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Johnson & Johnson Vision Care, Inc. Clinical Trial, Johnson & Johnson Vision Care, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 14, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 16, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 16, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 22, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 23, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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