Clinical Performance of Two Commercial, Daily Disposable Contact Lenses

NCT ID: NCT05010512

Last Updated: 2022-11-08

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-31

Study Completion Date

2021-10-12

Brief Summary

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The purpose of this study is to compare the clinical performance of DAILIES TOTAL1 ( DT1) contact lenses with Infuse contact lenses.

Detailed Description

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Subjects will wear two products and be expected to attend 3 office visits. The individual duration of participation will be approximately 3 weeks, which includes 16 to 22 days of lens wear.

Conditions

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Refractive Errors 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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DT1, then Infuse

Delefilcon A contact lenses worn first, with kalifilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 (-0/+3) days on a daily wear, daily disposable basis.

Group Type OTHER

Delefilcon A contact lenses

Intervention Type DEVICE

Commercially available silicone hydrogel contact lenses used as indicated

Kalifilcon A contact lenses

Intervention Type DEVICE

Commercially available silicone hydrogel contact lenses used as indicated

Infuse, then DT1

Kalifilcon A contact lenses worn first, with delefilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 (-0/+3) days on a daily wear, daily disposable basis.

Group Type OTHER

Delefilcon A contact lenses

Intervention Type DEVICE

Commercially available silicone hydrogel contact lenses used as indicated

Kalifilcon A contact lenses

Intervention Type DEVICE

Commercially available silicone hydrogel contact lenses used as indicated

Interventions

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Delefilcon A contact lenses

Commercially available silicone hydrogel contact lenses used as indicated

Intervention Type DEVICE

Kalifilcon A contact lenses

Commercially available silicone hydrogel contact lenses used as indicated

Intervention Type DEVICE

Other Intervention Names

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DAILIES TOTAL1® DT1 Bausch + Lomb INFUSE™ Infuse

Eligibility Criteria

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Inclusion Criteria

* Habitually wears soft contact lenses in both eyes at least 5 days per week and at least 10 hours per day;
* At least 3 months of contact lens wearing experience;
* Less than or equal to 0.75 diopter (D) astigmatism in each eye;
* Best Corrected Visual Acuity (BCVA) better than or equal to 20/25 in each eye.

Exclusion Criteria

* Current/previous DAILIES TOTAL1 and/or Infuse habitual lens wearer;
* Monovision and/or multifocal lens wearer;
* Routinely sleeps in habitual contact lenses.
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 6355

Orlando, Florida, United States

Site Status

Alcon Investigator 6418

Tallahassee, Florida, United States

Site Status

Alcon Investigator 3950

Bloomington, Illinois, United States

Site Status

Alcon Investigator 6614

Franklin Park, Illinois, United States

Site Status

Alcon Investigator 6583

Eden Prairie, Minnesota, 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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CLU484-P002

Identifier Type: -

Identifier Source: org_study_id

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