Clinical Performance of Two Daily Disposable Soft Contact Lenses

NCT ID: NCT05138783

Last Updated: 2023-04-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-12

Study Completion Date

2022-03-07

Brief Summary

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The purpose of this study is to compare the clinical performance of PRECISION1 contact lenses with Biotrue contact lenses.

Detailed Description

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Subjects will be expected to attend 3 visits. Subjects will be expected to wear their study contact lenses every day for at least 10 hours per day over an 8-day period for each study lens type. The total duration of a subject's participation in the study 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 Biotrue

Verofilcon A contact lenses worn first, with nesofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) at least 10 hours per day for 8 -0/+3 days. A fresh pair of lenses will be worn each day.

Group Type OTHER

Verofilcon A contact lenses

Intervention Type DEVICE

Spherical soft contact lenses for daily disposable wear

Nesofilcon A contact lenses

Intervention Type DEVICE

Spherical soft contact lenses for daily disposable wear

Biotrue, then PRECISION1

Nesofilcon 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) at least 10 hours per day for 8 -0/+3 days. A fresh pair of lenses will be worn each day.

Group Type OTHER

Verofilcon A contact lenses

Intervention Type DEVICE

Spherical soft contact lenses for daily disposable wear

Nesofilcon 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

Nesofilcon A contact lenses

Spherical soft contact lenses for daily disposable wear

Intervention Type DEVICE

Other Intervention Names

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PRECISION1™ Biotrue® ONEday

Eligibility Criteria

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Inclusion Criteria

* Successful wear 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.
* 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 the day prior to Visit 2 and the day prior to Visit 3.

Exclusion Criteria

* Participation in a clinical trial within the previous 30 days or currently enrolled in any clinical trial.
* Habitual PRECISION1, Biotrue, and DAILIES TOTAL1 contact lens wear.
* Monovision and multifocal lens wear.
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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Kindred Optics at Maitland Vision

Maitland, Florida, United States

Site Status

Tallahassee Eye Center

Tallahassee, Florida, United States

Site Status

Franklin Park Eye Center PC

Franklin Park, Illinois, United States

Site Status

Heart of America Eye Care

Shawnee Mission, Kansas, United States

Site Status

Complete Eye Care Of Medina

Medina, Minnesota, United States

Site Status

ProCare Vision Centers, Inc.

Granville, Ohio, United States

Site Status

Clarke EyeCare Center

Wichita Falls, Texas, United States

Site Status

Stine Eye Center

Weston, Wisconsin, 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-P006

Identifier Type: -

Identifier Source: org_study_id

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