Presbyopic Wear Experience With Multifocal Lenses Compared to Single Vision Lenses and Reading Glasses

NCT ID: NCT07218731

Last Updated: 2025-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-30

Study Completion Date

2026-06-30

Brief Summary

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The purpose of the study is to assess participant experience when wearing multifocal contact lenses compared to spherical contact lenses with reading glasses.

Detailed Description

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Conditions

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Presbyopia Correction Presbyopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Multifocal contact lenses

multifocal contact lenses

Group Type ACTIVE_COMPARATOR

Multifocal contact lenses

Intervention Type DEVICE

Multifocal contact lenses

Spherical contact lenses with reading glasses

spherical contact lenses used with reading glasses

Group Type ACTIVE_COMPARATOR

Spherical contact lenses

Intervention Type DEVICE

spherical contact lenses

Interventions

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Multifocal contact lenses

Multifocal contact lenses

Intervention Type DEVICE

Spherical contact lenses

spherical contact lenses

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. At least 40 years of age.
2. Ability to give informed consent.
3. Subjects must have corrected distance visual acuity in both eyes equivalent to 20/25 or better at the screening visit.
4. Require an add power of +0.75 D or greater when tested at 40cm.
5. Good general health defined by medication use that has not changed within the last 30 days and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the Investigator.

Exclusion Criteria

1. Current or active inflammation or infection as determined by the Investigator.
2. Current eye disease, infection or inflammation that affects the surface of the eye such as but not limited to moderate or greater blepharitis and ocular allergy.
3. History of refractive surgery.
4. Known history of allergy or sensitivity to contact lens solutions and/or sodium fluorescein.
5. Is pregnant or lactating or planning a pregnancy during enrollment of the study.
6. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable.
7. Have been diagnosed with dry eye previously
8. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ohio State University

OTHER

Sponsor Role lead

Responsible Party

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Jennifer Fogt

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Ohio State University College of Optometry

Columbus, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Study Coordinators

Role: CONTACT

614-292-8858

Other Identifiers

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STUDY20252007

Identifier Type: -

Identifier Source: org_study_id

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