Status:
COMPLETED
The Role of Spectral Filtering in a Spectrally Adjustable Ocular Photosensitivity Analyzer
Lead Sponsor:
Johnson & Johnson Vision Care, Inc.
Conditions:
Photosensitivity
Eligibility:
All Genders
18-30 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 16 2022
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT04811079
Start Date
July 14 2021
End Date
May 16 2022
Last Update
April 25 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Miami Health - Bascom Palmer Eye Institute
Coral Gables, Florida, United States, 33146