Evaluation of Wear Experience With a Daily Disposable Contact Lens

NCT ID: NCT04296877

Last Updated: 2023-03-07

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

2020-03-10

Study Completion Date

2020-12-01

Brief Summary

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To evaluate the wear experience of current two-week contact lens wearers after they have been fit into a daily disposable contact lens. This is a single arm, non-comparative study.

Detailed Description

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This is a single arm, non-comparative study. All participants were habitual lens wearers of the same brand of lenses, and were re-fit with the study lenses.

Conditions

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Contact Lens

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is a single arm, non-comparative study.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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All study participants

All subjects are fit into daily disposable contact lenses after wearing their optimized habitual contact lenses for \~ 1 week. Subjects are requested to wear the lenses for two weeks, for a minimum of at least 6 hours per day for 10 days.

Group Type EXPERIMENTAL

Daily Disposable Contact Lens

Intervention Type DEVICE

Soft, daily disposable spherical contact lens used to correct distance vision.

Interventions

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Daily Disposable Contact Lens

Soft, daily disposable spherical contact lens used to correct distance vision.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Must be current Acuvue® Oasys® spherical contact lens wearers.
* 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.
* Either gender.
* Any racial or ethnic origin.

Exclusion Criteria

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

18 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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2020H0019

Identifier Type: -

Identifier Source: org_study_id

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