Clinical Comparison of 2 Daily Disposable Toric Soft Contact Lenses

NCT ID: NCT05039112

Last Updated: 2021-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-28

Study Completion Date

2021-11-29

Brief Summary

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The purpose of this study to evaluate the overall performance of PRECISION1™ for Astigmatism contact lenses with MyDay® Toric contact lenses.

Detailed Description

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Subjects will be expected to attend 4 visits and wear study lenses daily for approximately 10 hours per day. On the day prior to the Week 1 Follow-up visit of each crossover period, subjects will be asked to wear the respective study lens for at least 16 hours. The expected duration of subject participation in the study is approximately 3 weeks.

Conditions

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Refractive Errors Astigmatism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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P1fA, then MyDay Toric

Verofilcon A toric contact lenses worn first, with stenfilcon A toric contact lenses worn second, as randomized. Each product 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, used as indicated

Stenfilcon A toric contact lenses

Intervention Type DEVICE

Soft contact lenses for optical correction of astigmatism, used as indicated

MyDay Toric, then P1fA

Stenfilcon A toric contact lenses worn first, with verofilcon A toric contact lenses worn second, as randomized. Each product 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, used as indicated

Stenfilcon A toric contact lenses

Intervention Type DEVICE

Soft contact lenses for optical correction of astigmatism, used as indicated

Interventions

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Verofilcon A toric contact lenses

Soft contact lenses for optical correction of astigmatism, used as indicated

Intervention Type DEVICE

Stenfilcon A toric contact lenses

Soft contact lenses for optical correction of astigmatism, used as indicated

Intervention Type DEVICE

Other Intervention Names

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PRECISION1 for Astigmatism P1fA MyDay Toric

Eligibility Criteria

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Inclusion Criteria

* Successful wear of toric soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
* Willing to wear study contact lenses for at least 16 hours on the day prior to the Week 1 Follow up visit of each lens type.

Exclusion Criteria

* Current/previous wear of PRECISION1 for Astigmatism or MyDay Toric contact lenses.
* Current wear of spherical contact lenses.
* Wears habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week).
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 6565

Maitland, Florida, United States

Site Status

Alcon Investigator 6567

Pittsburg, Kansas, United States

Site Status

Alcon Investigator 8097

Sterling Heights, Michigan, United States

Site Status

Alcon Investigator 6313

Powell, Ohio, United States

Site Status

Alcon Investigator 6401

Warwick, Rhode Island, United States

Site Status

Alcon Investigator 6353

Memphis, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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CLA306-E001

Identifier Type: -

Identifier Source: org_study_id

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