Evaluation of Soft Multifocal Lenses in Presbyopic Previous Contact Lens Wearers

NCT06053463 | Completed Results FDA Device

• 1 other identifier: 2023H0245
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

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.

Conditions

Presbyopia

Keywords

contact lenses; Multifocal contact lenses

Outcome Measures

Primary Outcomes (2)

• Visual Analog Scale

  Visual Analog Scale survey of lens wear symptoms (vision) with contact lenses; percentage of participants with positive scores (\> 50).

  1 month

• Quality of Life Survey

  Assessment of the participant's quality of life with the daily disposable multifocal contact lenses; percentage of participants with VAS scores greater than 50 on satisfaction survey.

  1 month

Study Arms (1)

Lens wear experience

EXPERIMENTAL

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

Device: Daily disposable multifocal soft contact lens

Interventions

Daily disposable multifocal soft contact lens DEVICE

Daily disposable multifocal soft contact lens that will be worn for 1 month.

Lens wear experience

Eligibility Criteria

• Age: 38 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jennifer Fogt: lead
• Alcon Research: collaborator

Study Sites (2)

The Ohio State University College of Optometry

Columbus, Ohio, 43210, United States

Location

ProCare Vision Center

Granville, Ohio, 43023, United States

Location

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Jennifer Fogt
• Organization: The Ohio State University College of Optometry

fogt.78@osu.edu

614-292-0882

Study Officials

• Jennifer Fogt, OD, MS

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: September 25, 2023
• Study Start: October 6, 2023
• Primary Completion: May 23, 2024
• Study Completion: May 23, 2024
• Last Updated: November 27, 2024
• Results First Posted: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)