Clinical Comparison of Two Daily Disposable Toric Soft Contact Lenses

NCT ID: NCT05483127

Last Updated: 2023-11-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

153 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-13

Study Completion Date

2022-10-31

Brief Summary

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The primary purpose of this study is to demonstrate noninferiority in the visual acuity at distance when wearing PRECISION1™ for Astigmatism (P1fA) soft contact lenses compared to another commercially available, soft toric contact lens, MyDay® toric (MDT).

Detailed Description

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Study participants will wear each study lens type in 1 of 2 randomized, crossover sequences. Participants will be expected to attend 4 visits and wear study lenses for at least 10 hours per day. The total duration of an individual's participation in the study will be up to 28 days.

Conditions

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Astigmatism Ametropia Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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P1fA, then MDT

Verofilcon A toric soft contact lenses worn first, followed by stenfilcon A toric soft contact lenses, as randomized. Each study lens type will be worn for 8 (-0/+3) days for at least 10 hours per day. Lenses will be removed nightly and disposed of after a single use.

Group Type OTHER

Verofilcon A toric soft contact lenses

Intervention Type DEVICE

Soft contact lenses for optical correction of ametropia and astigmatism

Stenfilcon A toric soft contact lenses

Intervention Type DEVICE

Soft contact lenses for optical correction of ametropia and astigmatism

MDT, then P1fA

Stenfilcon A toric soft contact lenses worn first, followed by verofilcon A toric soft contact lenses, as randomized. Each study lens type will be worn for 8 (-0/+3) days for at least 10 hours per day. Lenses will be removed nightly and disposed of after a single use.

Group Type OTHER

Verofilcon A toric soft contact lenses

Intervention Type DEVICE

Soft contact lenses for optical correction of ametropia and astigmatism

Stenfilcon A toric soft contact lenses

Intervention Type DEVICE

Soft contact lenses for optical correction of ametropia and astigmatism

Interventions

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Verofilcon A toric soft contact lenses

Soft contact lenses for optical correction of ametropia and astigmatism

Intervention Type DEVICE

Stenfilcon A toric soft contact lenses

Soft contact lenses for optical correction of ametropia and astigmatism

Intervention Type DEVICE

Other Intervention Names

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PRECISION1™ for Astigmatism P1fA MyDay® toric soft contact lenses MDT

Eligibility Criteria

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Inclusion Criteria

* Successful wearers of toric soft contact lenses in both eyes with at least 3 months wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day.
* Able to wear contact lenses within a range of sphere \& cylinder power and axes.
* Willing to NOT use rewetting/lubricating drops at any time during the study.

Exclusion Criteria

* Current or previous P1fA and MDT habitual lens wearers.
* Monovision and multifocal lens wearers.
* Participation of the subject in a clinical trial within the previous 30 days or currently enrolled in any clinical trial.
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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Sr. Clinical Trial Lead, Vision Care

Role: STUDY_DIRECTOR

Alcon Research, LLC

Locations

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Kurata Eyecare Center

Los Angeles, California, United States

Site Status

Sabal Eye Care

Longwood, Florida, United States

Site Status

Drs. Giedd, P.A.

Maitland, Florida, United States

Site Status

Vision Health Institute

Orlando, Florida, United States

Site Status

Franklin Park Eye Center

Franklin Park, Illinois, United States

Site Status

Kannarr Eye Care

Pittsburg, Kansas, United States

Site Status

Heart of America Eye Care, P.A.

Shawnee Mission, Kansas, United States

Site Status

Wesley Optometric Consulting

Medina, Minnesota, United States

Site Status

ProCare Vision Center

Granville, Ohio, United States

Site Status

West Bay Eye Associates

Warwick, Rhode Island, United States

Site Status

Optometry Group, PLLC

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-P002

Identifier Type: -

Identifier Source: org_study_id

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