Clinical Performance of Two Daily Disposable Contact Lenses - Study 1

NCT ID: NCT03969290

Last Updated: 2019-08-22

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

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-05

Study Completion Date

2019-08-05

Brief Summary

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The purpose of this study is to evaluate end of day (EOD) visual acuity (VA) at distance when wearing Precision1™ contact lenses compared to Acuvue® Moist contact lenses.

Detailed Description

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The expected duration of subject participation in the study is 1-8 days, with 3 scheduled visits (Screening, Dispense, Exit).

Conditions

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Refractive Errors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Contralateral
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Sequence 1

Verofilcon A contact lens in the right eye (OD), with etafilcon A contact lens in the left eye (OS), as randomized. Lenses will be worn for one day, approximately 8 hours.

Group Type EXPERIMENTAL

Verofilcon A contact lenses

Intervention Type DEVICE

Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)

Etafilcon A contact lenses

Intervention Type DEVICE

Daily disposable contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)

Sequence 2

Etafilcon A contact lens in the right eye (OD), with verofilcon A contact lens in the left eye (OS), as randomized. Lenses will be worn for one day, approximately 8 hours.

Group Type ACTIVE_COMPARATOR

Verofilcon A contact lenses

Intervention Type DEVICE

Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)

Etafilcon A contact lenses

Intervention Type DEVICE

Daily disposable contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)

Interventions

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Verofilcon A contact lenses

Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)

Intervention Type DEVICE

Etafilcon A contact lenses

Daily disposable contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)

Intervention Type DEVICE

Other Intervention Names

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Precision1™ Acuvue® Moist

Eligibility Criteria

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Inclusion Criteria

* Able to understand and sign an approved Informed Consent form
* Successful wear of spherical soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day
* Best corrected VA of logMAR 0.10 or better in each eye
* Willing to discontinue artificial tears and rewetting drops during the study
* Able to wear contact lenses within the protocol-specified sphere power range

Exclusion Criteria

* Any anterior segment infection, inflammation, or abnormality or disease that contraindicates contact lens wear, as determined by the Investigator
* Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator
* History of ocular or intraocular surgery, including refractive surgery, and/or irregular cornea
* Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment
* Previous 3 years or current wearers of Acuvue Moist or DAILIES TOTAL1® 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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Alcon Research

Role: STUDY_DIRECTOR

Alcon Research

Locations

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Alcon Investigative Site

Jena, , Germany

Site Status

Countries

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Germany

Other Identifiers

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CLE383-P001

Identifier Type: -

Identifier Source: org_study_id

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