Wear Experience With Daily Contact Lenses Over a Long Day

NCT ID: NCT04535310

Last Updated: 2023-02-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-13

Study Completion Date

2021-03-31

Brief Summary

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This study is evaluating the wear experience of a daily contact lens after 10, 12, 14, and 16 hours of lens wear.

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

TREATMENT

Blinding Strategy

NONE

Study Groups

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Daily Disposable Contact Lens

All subjects are fit into Precision1® contact lenses. Subjects are requested to wear the lenses for a total of two weeks.

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

* Must be a current spherical contact lens wearer with longs days of lens wear.
* 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).
* Recent eye exam within the past year.
* Must have a working smart phone and be willing to download an app and/or receive and respond to texts.
* Ability to give informed consent.
* Willing to spend time for the study. Subjects will be required to attend three study visits, wear contact lenses on days between study visits, and must respond to push-notifications and/or texts on a smart phone for 5 days between visits 2 and 3.

Exclusion Criteria

* No current ocular inflammation or infection as assessed by the study investigator.
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

Associate Professor Clinical

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jennifer Fogt, OD, MS

Role: PRINCIPAL_INVESTIGATOR

The Ohio State University College of Optometry

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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2020H0324

Identifier Type: -

Identifier Source: org_study_id

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