Evaluation of Wear Experience With Daily Disposable and Monthly Replacement Toric Contact Lenses

NCT ID: NCT05580575

Last Updated: 2024-04-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2023-03-09

Brief Summary

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Comparison of wear experience with daily disposable and monthly replacement soft contact lenses in contact lens wearers who have astigmatism.

Detailed Description

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Conditions

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Astigmatism Bilateral

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Daily disposable lens worn first, reusable lens worn second

Subject will wear each contact lenses for 30 days during the day only.

Group Type EXPERIMENTAL

Daily disposable toric soft contact lens

Intervention Type DEVICE

Daily disposable toric soft contact lens

Monthly replacement toric daily wear soft contact lens

Intervention Type DEVICE

Monthly replacement toric daily wear soft contact lens

Reusable lens worn first, daily disposable lens worn second

Subject will wear each contact lenses for 30 days during the day only.

Group Type EXPERIMENTAL

Daily disposable toric soft contact lens

Intervention Type DEVICE

Daily disposable toric soft contact lens

Monthly replacement toric daily wear soft contact lens

Intervention Type DEVICE

Monthly replacement toric daily wear soft contact lens

Interventions

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Daily disposable toric soft contact lens

Daily disposable toric soft contact lens

Intervention Type DEVICE

Monthly replacement toric daily wear soft contact lens

Monthly replacement toric daily wear soft contact lens

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subjects must be current soft lens wearers in both eyes.
* Subjects must have 20/25 or better distance visual acuity with current lenses (entering acuity).
* 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)
* Ability to give informed consent
* Willing to spend time for the study. Subjects will be required to attend two study visits and wear contact lenses on days between study visits.
* Either gender
* Any racial or ethnic origin

Exclusion Criteria

* Participants cannot be pregnant or lactating.
* Participants cannot be current wearers of the study lenses
* No current ocular inflammation or infection as assessed by the study investigator
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ohio State University

OTHER

Sponsor Role lead

Responsible Party

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Jennifer Fogt

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Complete Eye Care of Medina

Medina, Minnesota, United States

Site Status

The Ohio State University College of Optometry

Columbus, Ohio, United States

Site Status

ProCare Vision Center

Granville, Ohio, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2022H0270

Identifier Type: -

Identifier Source: org_study_id

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