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Evaluation of Soft Multifocal Lenses in Presbyopic Previous Contact Lens Wearers

Primary Purpose

Presbyopia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Daily disposable multifocal soft contact lens
Sponsored by
Jennifer Fogt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Presbyopia focused on measuring contact lenses, Multifocal contact lenses

Eligibility Criteria

38 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Ability to give informed consent. Any gender. Any racial or ethnic origin. At least 38 years of age or older. Willing to spend time for the study. Three visits are required to complete the study, and additional follow up visits could be scheduled if needed. Subjects must have corrected distance visual acuity in both eyes equivalent to 20/25 or better at the screening visit. Spectacle sphere power range between +6.00 to -10.00. Previously dropped out of contact lens wear due to vision or vision and discomfort. Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the PI Exclusion Criteria: Current or active ocular inflammation or infection as determined by the Investigator. Astigmatism ≥ 1.00 D in either eye. History of previous eye surgery. Strabismus or binocular vision abnormalities that prevent completion of testing, at the discretion of the Investigator. Demonstration or history of corneal ectasia or keratoconus. Pregnant or lactating

Sites / Locations

  • The Ohio State University College of OptometryRecruiting
  • ProCare Vision CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lens wear experience

Arm Description

Subject will wear contact lenses for about a month during the day.

Outcomes

Primary Outcome Measures

Visual Analog Scale
Visual Analog Scale survey of lens wear symptoms (comfort, dryness, vision) with contact lenses
Quality of Life Survey
Assessment of the participant's quality of life with the daily disposable multifocal contact lenses

Secondary Outcome Measures

Full Information

First Posted
September 12, 2023
Last Updated
October 18, 2023
Sponsor
Jennifer Fogt
Collaborators
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT06053463
Brief Title
Evaluation of Soft Multifocal Lenses in Presbyopic Previous Contact Lens Wearers
Official Title
Evaluation of Soft Multifocal Lenses in Presbyopic Previous Contact Lens Wearers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 6, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jennifer Fogt
Collaborators
Alcon Research

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.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To explore the wear experience in Dailies TOTAL1 Multifocal contact lenses in presbyopic adults who have previously dropped out of contact lens wear.
Detailed Description
The purpose of this study is to evaluate the wear experience of people with presbyopia who previously dropped out of contact lens wear when fit with a Delefilcon A soft lens multifocal lens. Investigators expect to enroll a relatively equal amount of former soft multifocal contact lens wearers who dropped out due to poor vision at distance or near and single vision wearers who dropped out due to poor near vision. The key endpoints include Visual Analog Scale survey of lens wear symptoms (comfort, dryness, vision) with contact lenses and assessment of the participant's quality of life with the Dailies TOTAL1 Multifocal® contact lenses.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia
Keywords
contact lenses, Multifocal contact lenses

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Lens wear experience
Arm Type
Experimental
Arm Description
Subject will wear contact lenses for about a month during the day.
Intervention Type
Device
Intervention Name(s)
Daily disposable multifocal soft contact lens
Intervention Description
Daily disposable multifocal soft contact lens that will be worn for 1 month.
Primary Outcome Measure Information:
Title
Visual Analog Scale
Description
Visual Analog Scale survey of lens wear symptoms (comfort, dryness, vision) with contact lenses
Time Frame
1 month
Title
Quality of Life Survey
Description
Assessment of the participant's quality of life with the daily disposable multifocal contact lenses
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Ability to give informed consent. Any gender. Any racial or ethnic origin. At least 38 years of age or older. Willing to spend time for the study. Three visits are required to complete the study, and additional follow up visits could be scheduled if needed. Subjects must have corrected distance visual acuity in both eyes equivalent to 20/25 or better at the screening visit. Spectacle sphere power range between +6.00 to -10.00. Previously dropped out of contact lens wear due to vision or vision and discomfort. Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the PI Exclusion Criteria: Current or active ocular inflammation or infection as determined by the Investigator. Astigmatism ≥ 1.00 D in either eye. History of previous eye surgery. Strabismus or binocular vision abnormalities that prevent completion of testing, at the discretion of the Investigator. Demonstration or history of corneal ectasia or keratoconus. Pregnant or lactating
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emma M Ollis, BS
Phone
614-292-8858
Email
OPT-EyeStudies@osu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Fogt, OD, MS
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Fogt, OD, MS
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University College of Optometry
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emma M Ollis, BS
Phone
614-292-8858
Email
OPT-EyeStudies@osu.edu
First Name & Middle Initial & Last Name & Degree
Jennifer Fogt, OD, MS
Facility Name
ProCare Vision Center
City
Granville
State/Province
Ohio
ZIP/Postal Code
43023
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katherine Bickle, OD, PhD
Phone
740-587-3937
Email
kbickle12@yahoo.com
First Name & Middle Initial & Last Name & Degree
Kay Batson
Phone
740-587-3937
Email
kaybatson@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of Soft Multifocal Lenses in Presbyopic Previous Contact Lens Wearers

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