The Role of Spectral Filtering in a Spectrally Adjustable Ocular Photosensitivity Analyzer
1 other identifier
interventional
53
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 22, 2021
CompletedFirst Posted
Study publicly available on registry
March 23, 2021
CompletedStudy Start
First participant enrolled
July 14, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 16, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 16, 2022
CompletedApril 25, 2025
April 1, 2025
10 months
March 22, 2021
April 24, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (10)
Spectacle Filter Sequence 1
EXPERIMENTAL(419nm, 437nm, 373nm, 456nm, 476nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 1.
Spectacle Filter Sequence 2
EXPERIMENTAL(437nm, 456nm, 419nm, 476nm, 373nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 2.
Spectacle Filter Sequence 3
EXPERIMENTAL(456nm, 476nm, 437nm, 373nm, 419nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 3.
Spectacle Filter Sequence 4
EXPERIMENTAL(476nm, 373nm, 456nm, 419nm, 437nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 4.
Spectacle Filter Sequence 5
EXPERIMENTAL(373nm, 419nm, 476nm, 437nm, 456nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 5.
Spectacle Filter Sequence 6
EXPERIMENTAL(476nm, 456nm, 373nm, 437nm, 419nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 6.
Spectacle Filter Sequence 7
EXPERIMENTAL(373nm, 476nm, 419nm, 456nm, 437nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 7.
Spectacle Filter Sequence 8
EXPERIMENTAL(419nm, 373nm, 437nm, 476nm, 456nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 8.
Spectacle Filter Sequence 9
EXPERIMENTAL(437nm, 419nm, 456nm, 373nm, 476nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 9.
Spectacle Filter Sequence 10
EXPERIMENTAL(456nm, 437nm, 476nm, 419nm, 373nm) Eligible subjects will be enrolled in Spectacle Filter Sequence 10.
Interventions
TEST
TEST
TEST
TEST
CONTROL
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Miami Health - Bascom Palmer Eye Institute
Coral Gables, Florida, 33146, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Vision Care, Inc. Clinical Trial
Johnson & Johnson Vision Care, Inc.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2021
First Posted
March 23, 2021
Study Start
July 14, 2021
Primary Completion
May 16, 2022
Study Completion
May 16, 2022
Last Updated
April 25, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
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