Clinical Performance of Two Daily Disposable Toric Soft Contact Lenses

NCT ID: NCT04908488

Last Updated: 2022-10-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2021-09-22

Brief Summary

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The purpose of this study is to compare the clinical performance of PRECISION1™ for Astigmatism (P1fA) contact lenses with 1-DAY ACUVUE MOIST® for ASTIGMATISM (AMfA) contact lenses.

Detailed Description

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Subjects will be expected to attend 4 visits and wear study lenses daily for at least 10 hours per day. The total duration of subject participation will be up to 22 days.

Conditions

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Refractive Errors Ametropia Astigmatism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Subjects will receive treatment based upon the randomized treatment sequence assignment.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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P1fA, then AMfA

Verofilcon A toric contact lenses worn first, with etafilcon A toric contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality.

Group Type OTHER

Verofilcon A toric contact lenses

Intervention Type DEVICE

Soft contact lenses for optical correction of astigmatism

Etafilcon A toric contact lenses

Intervention Type DEVICE

Soft contact lenses for optical correction of astigmatism

AMfA, then P1fA

Etafilcon A toric contact lenses worn first, with verofilcon A toric contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality.

Group Type OTHER

Verofilcon A toric contact lenses

Intervention Type DEVICE

Soft contact lenses for optical correction of astigmatism

Etafilcon A toric contact lenses

Intervention Type DEVICE

Soft contact lenses for optical correction of astigmatism

Interventions

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Verofilcon A toric contact lenses

Soft contact lenses for optical correction of astigmatism

Intervention Type DEVICE

Etafilcon A toric contact lenses

Soft contact lenses for optical correction of astigmatism

Intervention Type DEVICE

Other Intervention Names

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PRECISION1™ for Astigmatism P1fA 1-DAY ACUVUE MOIST® for ASTIGMATISM AMfA

Eligibility Criteria

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Inclusion Criteria

* Successful wear of toric soft contact lenses in both eyes for a a minimum of 5 days per week and 10 hours per day during the past 3 months.

Exclusion Criteria

* Habitual PRECISION1 for Astigmatism or 1-DAY ACUVUE MOIST for ASTIGMATISM contact lens wearers.
* Any spherical monovision and multifocal lens wearers.
* Routinely sleeping in contact lenses for at least 1 night per week over the last 3 months prior to enrollment.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trial Lead, Vision Care

Role: STUDY_DIRECTOR

Alcon Research, LLC

Locations

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Alcon Investigator 8135

Los Angeles, California, United States

Site Status

Alcon Investigator 8062

Oakland, California, United States

Site Status

Alcon Investigator 6355

Orlando, Florida, United States

Site Status

Alcon Investigator 6614

Franklin Park, Illinois, United States

Site Status

Alcon Investigator 6645

Shawnee Mission, Kansas, United States

Site Status

Alcon Investigator 3382

Wyomissing, Pennsylvania, United States

Site Status

Alcon Investigator 6353

Memphis, Tennessee, United States

Site Status

Alcon Investigator 2786

Memphis, Tennessee, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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CLA306-P001

Identifier Type: -

Identifier Source: org_study_id

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