Wear Experience With Daily Toric Contact Lenses Over a Long Day

NCT ID: NCT04844281

Last Updated: 2023-11-29

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-11

Study Completion Date

2021-08-24

Brief Summary

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This study is evaluating the wear experience of a daily toric 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 Astigmatism of Both Eyes

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 Toric Contact Lens

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

Group Type EXPERIMENTAL

Precision1® Daily Disposable Toric Contact Lens

Intervention Type DEVICE

Soft, toric contact lens used to correct distance vision and astigmatism.

Interventions

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Precision1® Daily Disposable Toric Contact Lens

Soft, toric contact lens used to correct distance vision and astigmatism.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Must be current soft toric contact lens wearers with longs days of lens wear within the parameters of Precision1® lenses available.
* Distance visual acuity of 20/25 or better with current lenses.
* Recent eye exam in the last year.
* 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.
* Must have a working smart phone or device and be willing to receive and respond to texts and/or emails.
* Willing to spend time for the study, which includes three in-person study visits (with a possible fourth visit if needed), wearing contact lenses on days between study visits, and responding to communications on a smart phone or other electronic device on five weekdays between Visits 2 and 3.

Exclusion Criteria

* Current ocular inflammation or infection as assessed by the study investigator.
* Currently pregnant, lactating, or planning to become pregnant during the course of the study.
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 of Clinical Optometry

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Ohio State University

Columbus, Ohio, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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2020H0559

Identifier Type: -

Identifier Source: org_study_id