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

Photosensitivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04811079
• Other study ID #: CR-6402
• Status: Completed
• Phase: N/A
• Start date: July 14, 2021
• Est. completion date: May 16, 2022

Study information

• Verified date: June 2023
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: May 16, 2022
• Est. primary completion date: May 16, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Photophobia
• Photosensitivity
• Photosensitivity Disorders

Intervention

Other:
• 419 nm Spectacle Filter
TEST
• 437 nm Spectacle Filter
TEST
• 456 nm Spectacle Filter
TEST
• 476 nm Spectacle Filter
TEST
• 373 nm Spectacle Filter
CONTROL

Locations

Country	Name	City	State
United States	University of Miami Health - Bascom Palmer Eye Institute	Coral Gables	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	at approximately 2-week follow-up