Clinical Comparison of Two Daily Disposable Contact Lenses

NCT ID: NCT04865354

Last Updated: 2022-07-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-17

Study Completion Date

2021-06-27

Brief Summary

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The purpose of this study is to compare the clinical performance of PRECISION1™ contact lenses to Clariti® 1 day contact lenses.

Detailed Description

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Subjects will be expected to attend 3 study visits and wear the study lenses daily for at least 10 hours per day. On the day prior to Visits 2 and 3, subjects will be expected to wear the study lenses for at least 16 hours. The total duration of subject participation will be up to 22 days.

Conditions

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Refractive Errors

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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PRECISION1, then Clariti 1-Day

Verofilcon A contact lenses worn first, with somofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 days in a daily disposable modality.

Group Type OTHER

Verofilcon A contact lenses

Intervention Type DEVICE

Spherical soft contact lenses for daily disposable wear

Somofilcon A contact lenses

Intervention Type DEVICE

Spherical soft contact lenses for daily disposable wear

Clariti 1-Day, then PRECISION1

Somofilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 days in a daily disposable modality.

Group Type OTHER

Verofilcon A contact lenses

Intervention Type DEVICE

Spherical soft contact lenses for daily disposable wear

Somofilcon A contact lenses

Intervention Type DEVICE

Spherical soft contact lenses for daily disposable wear

Interventions

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Verofilcon A contact lenses

Spherical soft contact lenses for daily disposable wear

Intervention Type DEVICE

Somofilcon A contact lenses

Spherical soft contact lenses for daily disposable wear

Intervention Type DEVICE

Other Intervention Names

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PRECISION1 Clariti 1-Day

Eligibility Criteria

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Inclusion Criteria

* Successful wearer of spherical soft contact lenses with at least 3 months wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day.
* Possess spectacles and willing to wear habitual spectacles for vision correction when study lenses are not worn, as needed.
* Willing to wear contact lenses for at least 16 hours on one of the days (day prior to each week 1 visit).

Exclusion Criteria

* Habitual PRECISION1, Clariti 1-Day, and DAILIES TOTAL1 contact lens wearers.
* Any monovision and multifocal lens wearers.
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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CDMA Clinical Trial Lead, Vision Care

Role: STUDY_DIRECTOR

Alcon Research, LLC

Locations

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Alcon Investigator 8106

San Francisco, California, United States

Site Status

Alcon Investigator 6565

Maitland, Florida, United States

Site Status

Alcon Investigator 6418

Tallahassee, 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 6402

Medina, Minnesota, United States

Site Status

Alcon Investigator 8046

Granville, Ohio, United States

Site Status

Alcon Investigator 8028

Wichita Falls, Texas, 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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CLE383-P005

Identifier Type: -

Identifier Source: org_study_id

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