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

March 12, 2024 updated by: Bausch & Lomb Incorporated

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
301

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

36 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Proportion of Subjects Agreeing With the Statement "Clear Vision: Near, Far, and In-between
Time Frame: 3 weeks
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bausch & Lomb Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 7, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 16, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 16, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 21, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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