Evaluation of Product Performance of a New Silicone Hydrogel Multifocal Contact Lens

A Study to Evaluate the Product Performance of a New Silicone Hydrogel Multifocal Contact Lens

The objective of this study is to evaluate the product performance of a new silicone hydrogel daily disposable multifocal contact lens, the Bausch + Lomb (kalifilcon A) Daily Disposable Multifocal Contact Lens, when worn by current soft contact lens wearers on a daily disposable wear basis

Study Overview

• Status: Completed
• Conditions: Myopia and Hyperopia and Presbyopia
• Intervention / Treatment: Device: new silicone hydrogel daily disposable multifocal contact lens, the Bausch + Lomb (kalifilcon A) Daily Disposable Multifocal Contact Lens

• Study Type: Interventional
• Enrollment (Actual): 301
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dan Donatello; Phone Number: 5853385306; Email: daniel.donatello@bauschcloud.com

Study Locations

• United States
  • California
    • San Diego, California, United States, 92123
      • Eric White OD Inc
    • San Francisco, California, United States, 94112
      • Lee & Woo Optometry
  • Colorado
    • Denver, Colorado, United States, 80246
      • Chester T Roe III MD Prof LLC
  • Florida
    • Jacksonville, Florida, United States, 32246
      • Pearle Vision
    • Orlando, Florida, United States, 32803
      • Vision Health Institute
    • Orlando, Florida, United States, 32803
      • Eola Eyes
    • Sarasota, Florida, United States, 34237
      • Golden Vision
  • Georgia
    • Decatur, Georgia, United States, 30035
      • The Eyecare Studio, LLC
  • Kansas
    • Leavenworth, Kansas, United States, 66048
      • Family Eyecare Center
    • Pittsburg, Kansas, United States, 66762
      • Kannarr EyeCare
  • Maine
    • Portland, Maine, United States, 04101
      • Casco Bay EyeCare
  • Minnesota
    • Edina, Minnesota, United States, 55436
      • Cornea and Contact Lens Institute of Minnesota
  • Missouri
    • Saint Louis, Missouri, United States, 63144
      • Koetting Associates
  • New York
    • Jamestown, New York, United States, 14701
      • Spectrum Eyecare
    • Vestal, New York, United States, 13850
      • Saccco Eye Group
  • North Carolina
    • Raleigh, North Carolina, United States, 27603
      • Oculus Research
    • Shelby, North Carolina, United States, 28150
      • CORE, Inc.
  • Rhode Island
    • Warwick, Rhode Island, United States, 02888
      • West Bay Eye Associates
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Total Eye Care, PA
    • Nashville, Tennessee, United States, 37205
      • Optometric Physicians of Middle Tennessee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subjects must be age 40 years or older on the date the ICF is signed and have the capacity to provide voluntary informed consent
• Subjects must be willing and able to comply with all treatment and follow-up/study procedures, as well as willing and able to refrain from using any contact lenses other than those provided for the duration of the study
• Subjects must be correctable through spherocylindrical refraction to 42 letters (0.1 logMAR) or better (distance, high contrast) in each eye
• Subjects must have clear central corneas and be free of any anterior segment disorders
• Subject must wear their current lenses for a minimum of 12 hours per day at least four days per week
• Subjects must habitually wear a multifocal lens in each eye
• Subjects must be an adapted multifocal soft contact lens wearer for a minimum of 6 months
• Subjects must require distance lens correction from +3.00 to -6.00 D in each eye
• Subjects must be presbyopic and require near add correction from +0.75 to +2.50 D in each eye
• Subjects must have access to an internet connection to complete an online survey and be able to receive text message

Exclusion Criteria:

• Subjects participating in any drug or device clinical investigation within 30 days prior to entry into this study and/or plan to do so during the period of study participation

• Subjects who are women of childbearing potential (those who are not surgically sterilized or postmenopausal) are excluded from participation in the investigation if they meet any one of the following conditions:

  • She is currently pregnant
  • She plans to become pregnant during the study
  • She is breastfeeding
• Subjects with any systemic disease currently affecting ocular health or that, in the Investigator's opinion, may have an effect on ocular health during the course of the study
• Subjects with an active ocular disease
• Subjects who have had any corneal surgery (e.g., refractive surgery)
• Subjects who have worn gas-permeable (GP) contact lenses within the last 30 days or who have worn polymethylmethacrylate (PMMA) lenses within the last 3 months
• Subjects who currently wear monovision or toric contact lenses
• Subjects who are not correctable to 32 letters (0.3 logMAR) with bilateral soft multifocal contact lenses
• Subjects with an ocular astigmatism >1.00 D in either eye
• Subjects with anisometropia (spherical equivalent) >2.00 D
• Subjects with any Grade ≥2 finding during the slit lamp examination. Subjects with corneal infiltrates of ANY GRADE are not eligible
• Any "Present" finding during the slit lamp examination that, in the Investigator's opinion, interferes with contact lens wear
• Any scar or neovascularization within the central 6 mm of the cornea. Subjects with minor peripheral corneal scarring (that does not extend into the central area) that, in the Investigator's opinion, does not interfere with contact lens wear are eligible for this study
• Subjects who are amblyopic
• Subjects using any systemic or topical ocular medication that will, in the Investigator's opinion, affect ocular physiology or lens performance
• Subjects who are allergic to any component in the study care products

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: e Bausch + Lomb (kalifilcon A) Daily Disposable Multifocal Contact Lens	Device: new silicone hydrogel daily disposable multifocal contact lens, the Bausch + Lomb (kalifilcon A) Daily Disposable Multifocal Contact Lens; new silicone hydrogel daily disposable multifocal contact lens, the Bausch + Lomb (kalifilcon A) Daily Disposable Multifocal Contact Lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of Subjects Agreeing With the Statement "Clear Vision: Near, Far, and In-between	3 weeks

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2022
• Primary Completion (Actual): January 16, 2023
• Study Completion (Actual): January 16, 2023

Study Registration Dates

• First Submitted: December 13, 2022
• First Submitted That Met QC Criteria: December 13, 2022
• First Posted (Actual): December 21, 2022

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia; Hyperopia
• Other Study ID Numbers: BL916

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