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

NCT ID: NCT04811079

Last Updated: 2025-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-14

Study Completion Date

2022-05-16

Brief Summary

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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.

Detailed Description

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Conditions

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Photosensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Spectacle Filter Sequence 1

(419nm, 437nm, 373nm, 456nm, 476nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 1.

Group Type EXPERIMENTAL

419 nm Spectacle Filter

Intervention Type OTHER

TEST

437 nm Spectacle Filter

Intervention Type OTHER

TEST

456 nm Spectacle Filter

Intervention Type OTHER

TEST

476 nm Spectacle Filter

Intervention Type OTHER

TEST

373 nm Spectacle Filter

Intervention Type OTHER

CONTROL

Spectacle Filter Sequence 2

(437nm, 456nm, 419nm, 476nm, 373nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 2.

Group Type EXPERIMENTAL

419 nm Spectacle Filter

Intervention Type OTHER

TEST

437 nm Spectacle Filter

Intervention Type OTHER

TEST

456 nm Spectacle Filter

Intervention Type OTHER

TEST

476 nm Spectacle Filter

Intervention Type OTHER

TEST

373 nm Spectacle Filter

Intervention Type OTHER

CONTROL

Spectacle Filter Sequence 3

(456nm, 476nm, 437nm, 373nm, 419nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 3.

Group Type EXPERIMENTAL

419 nm Spectacle Filter

Intervention Type OTHER

TEST

437 nm Spectacle Filter

Intervention Type OTHER

TEST

456 nm Spectacle Filter

Intervention Type OTHER

TEST

476 nm Spectacle Filter

Intervention Type OTHER

TEST

373 nm Spectacle Filter

Intervention Type OTHER

CONTROL

Spectacle Filter Sequence 4

(476nm, 373nm, 456nm, 419nm, 437nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 4.

Group Type EXPERIMENTAL

419 nm Spectacle Filter

Intervention Type OTHER

TEST

437 nm Spectacle Filter

Intervention Type OTHER

TEST

456 nm Spectacle Filter

Intervention Type OTHER

TEST

476 nm Spectacle Filter

Intervention Type OTHER

TEST

373 nm Spectacle Filter

Intervention Type OTHER

CONTROL

Spectacle Filter Sequence 5

(373nm, 419nm, 476nm, 437nm, 456nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 5.

Group Type EXPERIMENTAL

419 nm Spectacle Filter

Intervention Type OTHER

TEST

437 nm Spectacle Filter

Intervention Type OTHER

TEST

456 nm Spectacle Filter

Intervention Type OTHER

TEST

476 nm Spectacle Filter

Intervention Type OTHER

TEST

373 nm Spectacle Filter

Intervention Type OTHER

CONTROL

Spectacle Filter Sequence 6

(476nm, 456nm, 373nm, 437nm, 419nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 6.

Group Type EXPERIMENTAL

419 nm Spectacle Filter

Intervention Type OTHER

TEST

437 nm Spectacle Filter

Intervention Type OTHER

TEST

456 nm Spectacle Filter

Intervention Type OTHER

TEST

476 nm Spectacle Filter

Intervention Type OTHER

TEST

373 nm Spectacle Filter

Intervention Type OTHER

CONTROL

Spectacle Filter Sequence 7

(373nm, 476nm, 419nm, 456nm, 437nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 7.

Group Type EXPERIMENTAL

419 nm Spectacle Filter

Intervention Type OTHER

TEST

437 nm Spectacle Filter

Intervention Type OTHER

TEST

456 nm Spectacle Filter

Intervention Type OTHER

TEST

476 nm Spectacle Filter

Intervention Type OTHER

TEST

373 nm Spectacle Filter

Intervention Type OTHER

CONTROL

Spectacle Filter Sequence 8

(419nm, 373nm, 437nm, 476nm, 456nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 8.

Group Type EXPERIMENTAL

419 nm Spectacle Filter

Intervention Type OTHER

TEST

437 nm Spectacle Filter

Intervention Type OTHER

TEST

456 nm Spectacle Filter

Intervention Type OTHER

TEST

476 nm Spectacle Filter

Intervention Type OTHER

TEST

373 nm Spectacle Filter

Intervention Type OTHER

CONTROL

Spectacle Filter Sequence 9

(437nm, 419nm, 456nm, 373nm, 476nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 9.

Group Type EXPERIMENTAL

419 nm Spectacle Filter

Intervention Type OTHER

TEST

437 nm Spectacle Filter

Intervention Type OTHER

TEST

456 nm Spectacle Filter

Intervention Type OTHER

TEST

476 nm Spectacle Filter

Intervention Type OTHER

TEST

373 nm Spectacle Filter

Intervention Type OTHER

CONTROL

Spectacle Filter Sequence 10

(456nm, 437nm, 476nm, 419nm, 373nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 10.

Group Type EXPERIMENTAL

419 nm Spectacle Filter

Intervention Type OTHER

TEST

437 nm Spectacle Filter

Intervention Type OTHER

TEST

456 nm Spectacle Filter

Intervention Type OTHER

TEST

476 nm Spectacle Filter

Intervention Type OTHER

TEST

373 nm Spectacle Filter

Intervention Type OTHER

CONTROL

Interventions

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419 nm Spectacle Filter

TEST

Intervention Type OTHER

437 nm Spectacle Filter

TEST

Intervention Type OTHER

456 nm Spectacle Filter

TEST

Intervention Type OTHER

476 nm Spectacle Filter

TEST

Intervention Type OTHER

373 nm Spectacle Filter

CONTROL

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Johnson & Johnson Vision Care, Inc. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Vision Care, Inc.

Locations

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University of Miami Health - Bascom Palmer Eye Institute

Coral Gables, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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CR-6402

Identifier Type: -

Identifier Source: org_study_id

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