search
Back to results

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

Primary Purpose

Myopia and Hyperopia and Presbyopia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
new silicone hydrogel daily disposable multifocal contact lens, the Bausch + Lomb (kalifilcon A) Daily Disposable Multifocal Contact Lens
Sponsored by
Bausch & Lomb Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia and Hyperopia and Presbyopia

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Eric White OD IncRecruiting
  • Lee & Woo OptometryRecruiting
  • Chester T Roe III MD Prof LLCRecruiting
  • Pearle VisionRecruiting
  • Eola EyesRecruiting
  • Vision Health InstituteRecruiting
  • Golden VisionRecruiting
  • The Eyecare Studio, LLCRecruiting
  • Family Eyecare CenterRecruiting
  • Kannarr EyeCareRecruiting
  • Casco Bay EyeCareRecruiting
  • Cornea and Contact Lens Institute of MinnesotaRecruiting
  • Koetting AssociatesRecruiting
  • Spectrum EyecareRecruiting
  • Saccco Eye GroupRecruiting
  • Oculus ResearchRecruiting
  • CORE, Inc.Recruiting
  • West Bay Eye AssociatesRecruiting
  • Total Eye Care, PARecruiting
  • Optometric Physicians of Middle TennesseeRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

e Bausch + Lomb (kalifilcon A) Daily Disposable Multifocal Contact Lens

Arm Description

Outcomes

Primary Outcome Measures

proportion of subjects agreeing with the statement "Clear vision: near, far, and in-between

Secondary Outcome Measures

Full Information

First Posted
December 13, 2022
Last Updated
August 31, 2023
Sponsor
Bausch & Lomb Incorporated
search

1. Study Identification

Unique Protocol Identification Number
NCT05660577
Brief Title
Evaluation of Product Performance of a New Silicone Hydrogel Multifocal Contact Lens
Official Title
A Study to Evaluate the Product Performance of a New Silicone Hydrogel Multifocal Contact Lens
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 7, 2022 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia and Hyperopia and Presbyopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
e Bausch + Lomb (kalifilcon A) Daily Disposable Multifocal Contact Lens
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
new silicone hydrogel daily disposable multifocal contact lens, the Bausch + Lomb (kalifilcon A) Daily Disposable Multifocal Contact Lens
Intervention Description
new silicone hydrogel daily disposable multifocal contact lens, the Bausch + Lomb (kalifilcon A) Daily Disposable Multifocal Contact Lens
Primary Outcome Measure Information:
Title
proportion of subjects agreeing with the statement "Clear vision: near, far, and in-between
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dan Donatello
Phone
5853385306
Email
daniel.donatello@bauschcloud.com
Facility Information:
Facility Name
Eric White OD Inc
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric White
Facility Name
Lee & Woo Optometry
City
San Francisco
State/Province
California
ZIP/Postal Code
94112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kim Lee
Phone
415-269-3293
Email
drkimlee62@gmail.com
Facility Name
Chester T Roe III MD Prof LLC
City
Denver
State/Province
Colorado
ZIP/Postal Code
80246
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherwyn Vicksman
Phone
720-218-1075
Email
svicksman@drcroe.com
Facility Name
Pearle Vision
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32246
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jon Walker
Phone
904-998-9871
Email
JonWalkerOD@Me.com
Facility Name
Eola Eyes
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerry Giedd
Phone
407-927-7859
Email
KerryGieddOD@aol.com
Facility Name
Vision Health Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Perry, MD
Facility Name
Golden Vision
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34237
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wayne Golden
Phone
941-342-9711
Email
dr@goldenvisiononline.com
Facility Name
The Eyecare Studio, LLC
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30035
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keith Fishe
Phone
770-314-3756
Email
drfishe2@gmail.com
Facility Name
Family Eyecare Center
City
Leavenworth
State/Province
Kansas
ZIP/Postal Code
66048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Reddell
Phone
913-682-2929
Email
jreddell@feclc.com
Facility Name
Kannarr EyeCare
City
Pittsburg
State/Province
Kansas
ZIP/Postal Code
66762
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shane Kannarr, OD
First Name & Middle Initial & Last Name & Degree
Chris Jacquinot, OD
Facility Name
Casco Bay EyeCare
City
Portland
State/Province
Maine
ZIP/Postal Code
04101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven Goldstein
Phone
207-773-2020
Email
sgoldstein@cascobayeye.com
Facility Name
Cornea and Contact Lens Institute of Minnesota
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55436
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zachary Holland
Phone
952-300-2151
Email
zachary.holland10@gmail.com
Facility Name
Koetting Associates
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63144
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carmen Castellano, MD
First Name & Middle Initial & Last Name & Degree
Carmen Castellano
Facility Name
Spectrum Eyecare
City
Jamestown
State/Province
New York
ZIP/Postal Code
14701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Colburn
Phone
716-664-7601
Email
ccolburn@stny.rr.com
Facility Name
Saccco Eye Group
City
Vestal
State/Province
New York
ZIP/Postal Code
13850
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Sacco
Phone
607-343-0782
Email
asacco@stny.rr.com
Facility Name
Oculus Research
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27603
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erik Aune
Phone
919-346-6945
Email
info@oculusresearch@gmail.com
Facility Name
CORE, Inc.
City
Shelby
State/Province
North Carolina
ZIP/Postal Code
28150
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Vollmer
Phone
828-406-3878
Email
patrickvollmer23@gmail.com
Facility Name
West Bay Eye Associates
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02888
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen Montaquila
Phone
401-487-8482
Email
drmontaquila@westbayeye.com
Facility Name
Total Eye Care, PA
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caitlin Pearson
Phone
978-685-8900
Email
cpearson@oraclinical.com
Facility Name
Optometric Physicians of Middle Tennessee
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Durocher
Phone
615-519-6242
Email
RD@OPMT.COM

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs