Evaluation of Soft Multifocal Lenses in Presbyopic Previous Contact Lens Wearers

NCT ID: NCT06053463

Last Updated: 2024-11-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-06
• Study Completion Date: 2024-05-23

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.

Conditions

Presbyopia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lens wear experience

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

Group Type: EXPERIMENTAL

Daily disposable multifocal soft contact lens

Intervention Type: DEVICE

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

Interventions

Daily disposable multifocal soft contact lens

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 38 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: collaborator

Jennifer Fogt

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Fogt

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jennifer Fogt, OD, MS

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

The Ohio State University College of Optometry

Columbus, Ohio, United States

ProCare Vision Center

Granville, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2023H0245

Identifier Type: -

Identifier Source: org_study_id