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

Primary Purpose

Photosensitivity

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

419 nm Spectacle Filter

437 nm Spectacle Filter

456 nm Spectacle Filter

476 nm Spectacle Filter

373 nm Spectacle Filter

About this trial

This is an interventional treatment trial for Photosensitivity

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

University of Miami Health - Bascom Palmer Eye Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

Experimental

Arm Label

Spectacle Filter Sequence 1

Spectacle Filter Sequence 2

Spectacle Filter Sequence 3

Spectacle Filter Sequence 4

Spectacle Filter Sequence 5

Spectacle Filter Sequence 6

Spectacle Filter Sequence 7

Spectacle Filter Sequence 8

Spectacle Filter Sequence 9

Spectacle Filter Sequence 10

Arm Description

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

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

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

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

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04811079

First Posted

March 22, 2021

Last Updated

June 2, 2023

Sponsor

Johnson & Johnson Vision Care, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04811079

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

July 14, 2021 (Actual)

Primary Completion Date

May 16, 2022 (Actual)

Study Completion Date

May 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Johnson & Johnson Vision Care, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Photosensitivity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

53 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Spectacle Filter Sequence 1

Arm Type

Experimental

Arm Description

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

Arm Title

Spectacle Filter Sequence 2

Arm Type

Experimental

Arm Description

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

Arm Title

Spectacle Filter Sequence 3

Arm Type

Experimental

Arm Description

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

Arm Title

Spectacle Filter Sequence 4

Arm Type

Experimental

Arm Description

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

Arm Title

Spectacle Filter Sequence 5

Arm Type

Experimental

Arm Description

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

Arm Title

Spectacle Filter Sequence 6

Arm Type

Experimental

Arm Description

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

Arm Title

Spectacle Filter Sequence 7

Arm Type

Experimental

Arm Description

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

Arm Title

Spectacle Filter Sequence 8

Arm Type

Experimental

Arm Description

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

Arm Title

Spectacle Filter Sequence 9

Arm Type

Experimental

Arm Description

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

Arm Title

Spectacle Filter Sequence 10

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

419 nm Spectacle Filter

Intervention Description

TEST

Intervention Type

Other

Intervention Name(s)

437 nm Spectacle Filter

Intervention Description

TEST

Intervention Type

Other

Intervention Name(s)

456 nm Spectacle Filter

Intervention Description

TEST

Intervention Type

Other

Intervention Name(s)

476 nm Spectacle Filter

Intervention Description

TEST

Intervention Type

Other

Intervention Name(s)

373 nm Spectacle Filter

Intervention Description

CONTROL

Primary Outcome Measure Information:

Title

Visual Photosensitivity Threshold (VPT)

Description

Time Frame

at approximately 2-week follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Johnson & Johnson Vision Care, Inc. Clinical Trial

Organizational Affiliation

Johnson & Johnson Vision Care, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

University of Miami Health - Bascom Palmer Eye Institute

City

Coral Gables

State/Province

Florida

ZIP/Postal Code

33146

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

IPD Sharing URL

http://yoda.yale.edu

Learn more about this trial

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

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