Clinical trial NCT04995055: Evaluation of Multifocal Contact Lens Designs With and Without an HEV Blocker on Visual Function
Official title: Evaluation of Multifocal Contact Lens Designs With and Without an HEV Blocker on Visual Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Acuity
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2021-08-06
Enrollment: 37
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a single-masked, bilateral, controlled, randomized, 2x2 crossover, non-dispensing clinical trial to characterize the effects of an HEV-Blocker on several measures of visual function in a presbyopic population.


Eligibility criteria: Inclusion Criteria:

* Potential subjects must satisfy all of the following criteria to be enrolled in the study:

  1. Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form
  2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
  3. Be between at least 40 and not more than 70 years of age at the time of screening.
  4. Possess a wearable pair of spectacles that provide correction for distance vision.
  5. Be an adapted soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 8 hours per wear day, for 1 month of more duration).
  6. Be wearing a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if not respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire".
  7. The subject must have normal color perception as evidenced by reading 17 out of the first 21 Ishihara plates correctly.
  8. The subject's distance spherical equivalent of their refraction must be in the range of -1.00 D to -4.00 D.
  9. The subject's refractive cylinder must be ≤0.75 D in each eye.
  10. The subject's ADD power must be in the range of +0.75 D to +2.50 D in each eye.
  11. The subject must have best corrected distance visual acuity of 20/20-3 or better in each eye.

      Exclusion Criteria:
* Potential subjects who meet any of the following criteria will be excluded from participating in the study:

  1. Be currently pregnant or lactating.
  2. Any systemic disease (e.g., Sjögren's Syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study.
  3. Use of any of the following oral medications within 1 week prior to enrollment: oral retinoids, oral tetracyclines, oral phenothiazines, anticholinergics, oral/inhaled steroids, oral phosphodiesterase type 5 inhibitors, interferon alfa, antimycobacterial antibiotics, and nitroimidazole antibiotics. See Section 9.1 for additional details regarding excluded systemic medications.
  4. Any current use of ocular medication with the exception of rewetting drops.
  5. Any known hypersensitivity or allergic reaction to single use preservative free rewetting drops or sodium fluorescein.
  6. Any previous or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK dacryocystorhinostomy, cataract surgery, retinal surgery, peripheral iridotomy/iridectomy, etc.).
  7. Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.
  8. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
  9. Any active or ongoing ocular or systemic allergies that may interfere with contact lens wear.
  10. A history of amblyopia, strabismus or binocular vision abnormality.
  11. History of optic nerve or retinal disease or trauma
  12. Abnormal color vison.
  13. Any other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or corneal distortion
  14. Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA scale.
  15. Any current ocular infection or inflammation.

Primary outcomes:
measure: Starburst Diameter (mm)
timeFrame: 30-minutes post lens insertion
measure: Halos Diameter (mm)
timeFrame: 30-minutes post lens insertion
measure: Glare Disability Threshold
timeFrame: 30-minutes post lens insertion
Secondary outcomes:
measure: Glare Discomfort (mm)
timeFrame: 30-minutes post lens insertion
measure: Heterochromatic Contrast Threshold (HCT)
timeFrame: 30-minutes post lens insertion
measure: Two-Point Threshold (mm) With 403nm Filter
timeFrame: 30-minutes post lens insertion
measure: Two-Point Threshold (mm) Without 403nm Filter
timeFrame: 30-minutes post lens insertion
Other outcomes:
Locations:
city: Athens
country: United States
facility: University of Georgia
state: Georgia
Study officials:
affiliation: Johnson & Johnson Vision Care, Inc.
name: Johnson & Johnson Vision Care, Inc. Clinical Trial
role: STUDY_DIRECTOR
References: