Clinical Comparison of 4 Daily Disposable Soft Contact Lenses

NCT ID: NCT03349632

Last Updated: 2019-02-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-10

Study Completion Date

2018-02-16

Brief Summary

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The purpose of this study is to obtain on-eye performance data to inform contact lens product development and to further evaluate product performance in the intended population.

Detailed Description

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The expected duration of subject participation in the study is approximately 20 days with 3 scheduled visits. Each subject will evaluate the test contact lenses compared to 1 of 3 commercially available contact lenses.

Conditions

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Refractive Error

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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DD T2/Oasys 1-Day

Verofilcon A contact lenses and senofilcon A contact lenses worn in both eyes, each product, for 1 week on a daily wear basis, as randomized

Group Type OTHER

verofilcon A contact lenses

Intervention Type DEVICE

Investigational spherical silicone hydrogel contact lenses for daily disposable wear

senofilcon A contact lenses

Intervention Type DEVICE

Commercially available spherical silicone hydrogel contact lenses for daily disposable wear

DD T2/MyDay

Verofilcon A contact lenses and stenfilcon A contact lenses worn in both eyes, each product, for 1 week on a daily disposable basis, as randomized

Group Type OTHER

verofilcon A contact lenses

Intervention Type DEVICE

Investigational spherical silicone hydrogel contact lenses for daily disposable wear

stenfilcon A contact lenses

Intervention Type DEVICE

Commercially available spherical silicone hydrogel contact lenses for daily disposable wear

DD T2/Moist

Verofilcon A contact lenses and etafilcon A contact lenses worn in both eyes, each product, for 1 week on a daily disposable basis, as randomized

Group Type OTHER

verofilcon A contact lenses

Intervention Type DEVICE

Investigational spherical silicone hydrogel contact lenses for daily disposable wear

etafilcon A contact lenses

Intervention Type DEVICE

Commercially available spherical silicone hydrogel contact lenses for daily disposable wear

Interventions

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verofilcon A contact lenses

Investigational spherical silicone hydrogel contact lenses for daily disposable wear

Intervention Type DEVICE

senofilcon A contact lenses

Commercially available spherical silicone hydrogel contact lenses for daily disposable wear

Intervention Type DEVICE

stenfilcon A contact lenses

Commercially available spherical silicone hydrogel contact lenses for daily disposable wear

Intervention Type DEVICE

etafilcon A contact lenses

Commercially available spherical silicone hydrogel contact lenses for daily disposable wear

Intervention Type DEVICE

Other Intervention Names

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DDT2 ACUVUE OASYS® 1-Day with HydraLuxe™ Technology Oasys 1-Day MyDay® MyDay 1-Day ACUVUE® MOIST Moist

Eligibility Criteria

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Inclusion Criteria

* Able to understand and must sign an approved Informed Consent Form
* Successfully wears daily disposable spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months
* Best Corrected Visual Acuity of 20/25 Snellen or better in each eye
* Willing to stop wearing habitual contact lenses for the duration of study participation

Exclusion Criteria

* Any eye condition, surgery, disease, or use of medication that contraindicates contact lens wear, as determined by the Investigator.
* Routinely sleeps in habitual contact lenses
* Currently wears Oasys 1-Day, MyDay, or Moist 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

Locations

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Alcon Investigative Site

Maitland, Florida, United States

Site Status

Alcon Investigative Site

Pensacola, Florida, United States

Site Status

Alcon Investigative Site

Johns Creek, Georgia, 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-C004

Identifier Type: -

Identifier Source: org_study_id

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