Evaluation of Visual Acuity With a Reusable Toric Multifocal Contact Lens

The study is a bilateral, single-masked, single-arm, 4-visit dispensing study evaluating the visual performance of the study lenses.

Study Overview

• Status: Completed
• Conditions: Visual Acuity
• Intervention / Treatment: Device: Bausch + Lomb Ultra® Multifocal for Astigmatism

Detailed Description

The study is a bilateral, single-masked, single-arm, 4-visit dispensing study evaluating the visual performance of the study lenses.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32205
      • Vue Optical Boutique
    • Jacksonville, Florida, United States, 32256
      • Stam & Associates Eye Care
    • Jacksonville, Florida, United States, 32256
      • VRC-East
    • Maitland, Florida, United States, 32751
      • Maitland Vision Center
  • Georgia
    • Decatur, Georgia, United States, 13850
      • The Eyecare Studio
  • New York
    • Manhattan, New York, United States, 10222
      • Ctr For Opht and Vision Rsrch At Eye Associates Of New York
    • Vestal, New York, United States, 13850
      • Sacco Eye Group
  • Texas
    • Houston, Texas, United States, 77005
      • Vision Boutique
  • Virginia
    • Salem, Virginia, United States, 24153
      • Botetourt Eyecare LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 at least 40 and not more than 70 years of age at the time of screening.
  4. Own a wearable pair of spectacles if required for their distance vision.
  5. Be an adapted soft contact lens wearer in both eyes (i.e. has worn lenses a minimum of 2 days per week for at least 8 hours per wear day, for the past month).
  6. Be an existing wearer of a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire".
  7. Have distance spherical component of refraction in the range of either -1.25 D to -3.75 D or +1.25 to +3.75 D in each eye.
  8. Have refractive cylinder in the range of -0.75 D to -1.75 D in each eye, with their cylinder axis 90°±25°.
  9. Have near ADD power requirement in the range of +0.75 D to +2.50 D in each eye.

  10. Have best corrected distance visual acuity of 20/20-3 or better in each eye.

      Exclusion Criteria:

• The subject must not:

  1. Be currently pregnant or lactating.
  2. Have any active or ongoing ocular or systemic allergies that may interfere with contact lens wear.
  3. Have any active or ongoing systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but not be limited to, diabetes, hyperthyroidism, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens- Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g. hepatitis, tuberculosis).
  4. Use systemic medications that may interfere with contact lens wear or cause blurred vision. See section 9.1 for additional details regarding excluded systemic medications.
  5. Currently use ocular medication with the exception of rewetting drops.
  6. Have any known hypersensitivity or allergic reaction to single use preservative free rewetting drops, sodium fluorescein, or Biotrue® multipurpose solution.
  7. Have any previous, or planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, lid procedures, cataract surgery, retinal surgery, etc.).
  8. Have a history of amblyopia or strabismus.
  9. Have a history of herpetic keratitis.
  10. Have a history of irregular cornea.
  11. Have a history of pathological dry eye.
  12. Have participated in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
  13. Be an employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
  14. Have clinically significant (Grade 2 or greater) corneal edema, corneal vascularization, corneal staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular abnormalities which would contraindicate contact lens wear.
  15. Have entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions.
  16. Have any current ocular infection or inflammation.
  17. Have any current ocular abnormality that may interfere with contact lens wear.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Market Product; Eligible subjects will be dispensed the study lenses in a bilateral fashion and will be in the treatment for approximately 5 weeks.	Device: Bausch + Lomb Ultra® Multifocal for Astigmatism; Study Lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Binocular High Luminance High Contrast logMAR Visual Acuity	Binocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance high contrast condition. At distance (4 meters), VA is assessed using ETDRS (Early Treatment Diabetic Retinopathy Study) charts; while near (40 cm) and intermediate (64 cm) assessments were made using reduced Guillon-Poling charts. Letter-by-letter results calculated the visual performance score for each chart read. LogMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.	4-Week Follow-up

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2021
• Primary Completion (Actual): January 13, 2022
• Study Completion (Actual): January 13, 2022

Study Registration Dates

• First Submitted: August 3, 2021
• First Submitted That Met QC Criteria: August 3, 2021
• First Posted (Actual): August 11, 2021

Study Record Updates

• Last Update Posted (Actual): January 23, 2023
• Last Update Submitted That Met QC Criteria: January 5, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CR-6383

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes