## Protocol Section
### Identification Module
**NCT ID:** 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

#### Organization Study ID Info
**ID:** CR-6402
#### Organization
**Class:** INDUSTRY
**Full Name:** Johnson & Johnson Vision Care, Inc.
### Status Module
#### Completion Date
**Date:** 2022-05-16

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-06-05

**Type:** ACTUAL

**Last Update Submit Date:** 2023-06-02

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-05-16

**Type:** ACTUAL

#### Start Date
**Date:** 2021-07-14

**Type:** ACTUAL

**Status Verified Date:** 2023-06

#### Study First Post Date
**Date:** 2021-03-23
**Type:** ACTUAL
**Study First Submit Date:** 2021-03-22
**Study First Submit QC Date:** 2021-03-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Johnson & Johnson Vision Care, Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Photosensitivity

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 53

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- 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

**Label:** Spectacle Filter Sequence 1

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- 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

**Label:** Spectacle Filter Sequence 2

**Type:** EXPERIMENTAL

#### Arm Group 3

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

**Intervention Names:**

- 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

**Label:** Spectacle Filter Sequence 3

**Type:** EXPERIMENTAL

#### Arm Group 4

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

**Intervention Names:**

- 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

**Label:** Spectacle Filter Sequence 4

**Type:** EXPERIMENTAL

#### Arm Group 5

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

**Intervention Names:**

- 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

**Label:** Spectacle Filter Sequence 5

**Type:** EXPERIMENTAL

#### Arm Group 6

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

**Intervention Names:**

- 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

**Label:** Spectacle Filter Sequence 6

**Type:** EXPERIMENTAL

#### Arm Group 7

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

**Intervention Names:**

- 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

**Label:** Spectacle Filter Sequence 7

**Type:** EXPERIMENTAL

#### Arm Group 8

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

**Intervention Names:**

- 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

**Label:** Spectacle Filter Sequence 8

**Type:** EXPERIMENTAL

#### Arm Group 9

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

**Intervention Names:**

- 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

**Label:** Spectacle Filter Sequence 9

**Type:** EXPERIMENTAL

#### Arm Group 10

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

**Intervention Names:**

- 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

**Label:** Spectacle Filter Sequence 10

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Spectacle Filter Sequence 1

- Spectacle Filter Sequence 10

- 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

**Description:** TEST

**Name:** 419 nm Spectacle Filter

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Spectacle Filter Sequence 1

- Spectacle Filter Sequence 10

- 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

**Description:** TEST

**Name:** 437 nm Spectacle Filter

**Type:** OTHER

#### Intervention 3

**Arm Group Labels:**

- Spectacle Filter Sequence 1

- Spectacle Filter Sequence 10

- 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

**Description:** TEST

**Name:** 456 nm Spectacle Filter

**Type:** OTHER

#### Intervention 4

**Arm Group Labels:**

- Spectacle Filter Sequence 1

- Spectacle Filter Sequence 10

- 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

**Description:** TEST

**Name:** 476 nm Spectacle Filter

**Type:** OTHER

#### Intervention 5

**Arm Group Labels:**

- Spectacle Filter Sequence 1

- Spectacle Filter Sequence 10

- 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

**Description:** CONTROL

**Name:** 373 nm Spectacle Filter

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Visual Photosensitivity Threshold (VPT)

**Time Frame:** at approximately 2-week follow-up

### Eligibility Module

**Eligibility Criteria:** 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.

**Healthy Volunteers:** True

**Maximum Age:** 30 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Coral Gables

**Country:** United States

**Facility:** University of Miami Health - Bascom Palmer Eye Institute

**State:** Florida

**Zip:** 33146

#### Overall Officials

**Official 1:**

**Affiliation:** Johnson & Johnson Vision Care, Inc.

**Name:** Johnson & Johnson Vision Care, Inc. Clinical Trial

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**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:** YES

**URL:** http://yoda.yale.edu

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012871

- Term: Skin Diseases

- ID: D000014786

- Term: Vision Disorders

- ID: D000012678

- Term: Sensation Disorders

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000005128

- Term: Eye Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC11

- Name: Eye Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

### Condition Browse Module - Browse Leaves

- ID: M22550

- Name: Photophobia

- Relevance: HIGH

- As Found: Ocular Photosensitivity

- ID: M13686

- Name: Photosensitivity Disorders

- Relevance: HIGH

- As Found: Photosensitivity

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17530

- Name: Vision Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M15490

- Name: Sensation Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M8271

- Name: Eye Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000020795

- Term: Photophobia

- ID: D000010787

- Term: Photosensitivity Disorders

### Misc Info Module

- Version Holder: 2024-05-24
