Clinical trial NCT04811079: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Photosensitivity
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2021-03-23
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Visual Photosensitivity Threshold (VPT)
timeFrame: at approximately 2-week follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: University of Miami Health - Bascom Palmer Eye Institute
state: Florida
Study officials:
affiliation: Johnson & Johnson Vision Care, Inc.
name: Johnson & Johnson Vision Care, Inc. Clinical Trial
role: STUDY_DIRECTOR
References: