Evaluation of Soft Multifocal Lenses in Presbyopic Previous Contact Lens Wearers

To explore the wear experience in Dailies TOTAL1 Multifocal contact lenses in presbyopic adults who have previously dropped out of contact lens wear.

Study Overview

• Status: Recruiting
• Conditions: Presbyopia
• Intervention / Treatment: Device: Daily disposable multifocal soft contact lens

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emma M Ollis, BS; Phone Number: 614-292-8858; Email: OPT-EyeStudies@osu.edu
• Study Contact Backup: Name: Jennifer Fogt, OD, MS

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • The Ohio State University College of Optometry
      • Contact: Emma M Ollis, BS; Phone Number: 614-292-8858; Email: OPT-EyeStudies@osu.edu
      • Contact: Jennifer Fogt, OD, MS
    • Granville, Ohio, United States, 43023
      • Recruiting
      • ProCare Vision Center
      • Contact: Katherine Bickle, OD, PhD; Phone Number: 740-587-3937; Email: kbickle12@yahoo.com
      • Contact: Kay Batson; Phone Number: 740-587-3937; Email: kaybatson@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

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: Lens wear experience; Subject will wear contact lenses for about a month during the day.	Device: Daily disposable multifocal soft contact lens; Daily disposable multifocal soft contact lens that will be worn for 1 month.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale	Visual Analog Scale survey of lens wear symptoms (comfort, dryness, vision) with contact lenses	1 month
Quality of Life Survey	Assessment of the participant's quality of life with the daily disposable multifocal contact lenses	1 month

Collaborators and Investigators

• Sponsor: Jennifer Fogt
• Collaborators: Alcon Research
• Investigators: Principal Investigator: Jennifer Fogt, OD, MS, Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2023
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: September 12, 2023
• First Submitted That Met QC Criteria: September 12, 2023
• First Posted (Actual): September 25, 2023

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: contact lenses; Multifocal contact lenses
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia
• Other Study ID Numbers: 2023H0245

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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.: No