Evaluation of Wear Experience With Daily Contact Lenses

NCT ID: NCT05096156

Last Updated: 2023-11-08

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-28

Study Completion Date

2021-12-17

Brief Summary

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To evaluate the wear experience of current monthly replacement contact lens wearers after they have been fit into a daily disposable contact lens.

Detailed Description

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Conditions

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Contact Lens

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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All participants are fit with the study daily disposable lenses

All subjects are re-fit into their habitual monthly replacement contact lenses. Subjects are requested to wear the lenses for one week, for a minimum of at least 6 hours per day for 5 days. Upon return, subjects are refit into the daily disposable contact lenses.

Group Type EXPERIMENTAL

Precision1® Daily Disposable Contact Lens

Intervention Type DEVICE

Soft, spherical contact lens used to correct distance vision.

Interventions

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Precision1® Daily Disposable Contact Lens

Soft, spherical contact lens used to correct distance vision.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Currently wear Biofinity® monthly replacement spherical contact lenses.
* Distance visual acuity of 20/25 or better with current contact lenses.
* 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, which includes attending two study visits and wearing contact lenses on days between study visits.

Exclusion Criteria

* No current ocular inflammation or infection.
* Not currently pregnant or lactating.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role collaborator

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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The Ohio State University College of Optometry

Columbus, 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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2021H0118

Identifier Type: -

Identifier Source: org_study_id

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