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

• Sponsor: Johnson & Johnson Vision Care, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04811079
• Collaborator: (none)
• Enrollment: 53
• Location: 1
• Arms: 10
• Actual Duration (Months): 10.1
• Patients Per Site Per Month: 5.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Photosensitivity	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	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 53 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: The Role of Spectral Filtering in a Spectrally Adjustable Ocular Photosensitivity Analyzer
• Actual Study Start Date: Jul 14, 2021
• Actual Primary Completion Date: May 16, 2022
• Actual Study Completion Date: May 16, 2022

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Visual Photosensitivity Threshold (VPT) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 30 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Miami Health - Bascom Palmer Eye Institute	Coral Gables	Florida	United States	33146

Sponsors and Collaborators

• Johnson & Johnson Vision Care, Inc.

Investigators

• Study Director: Johnson & Johnson Vision Care, Inc. Clinical Trial, Johnson & Johnson Vision Care, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johnson & Johnson Vision Care, Inc.
• ClinicalTrials.gov Identifier: NCT04811079
• Other Study ID Numbers: CR-6402
• First Posted: Mar 23, 2021
• Last Update Posted: Jun 15, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Photophobia; Photosensitivity Disorders

Study Results

No Results Posted as of Jun 15, 2022