ACUVUE® OASYS With Transitions™ Light Intelligent Technology™ Clinical Performance Registry

NCT ID: NCT04116736

Last Updated: 2025-05-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

146 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-19

Study Completion Date

2023-03-10

Brief Summary

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This registry study is a one-year, one-visit, observational, prospective, open-label, two-arm, multi-center, multi-national, post-market study of approximately 300 patients who have recently been fitted with the ACUVUE® OASYS with Transitions™ and approximately 300 patients who have recently been fitted with spherical nonphotochromic reusable marketed silicone hydrogel contact lenses (of any brand). Eligible subjects will be asked to complete a Patient Registration Questionnaire several times throughout the year.

Detailed Description

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Conditions

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Vision Satisfaction in Bright Light

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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TEST Lens

Eligible subjects that are at least 18 years old, who have been recently fitted (within the last 2 months) with the ACUVUE® OASYS with Transitions™ will be asked to complete follow-up assessments performed online at approximately 2-weeks, 4-months, and 12-months following Visit 1.

ACUVUE® OASYS with Transitions™

Intervention Type DEVICE

JJVC Marketed Contact Lens

CONTROL Lens

Eligible subjects that are at least 18 years old, who have been recently fitted (within the last 2 months) with spherical non-photochromic reusable marketed silicone hydrogel contact lenses (of any brand) will be asked to complete follow-up assessments performed online at approximately 2-weeks, 4-months, and 12-months following Visit 1.

Silicone Hydrogel Contact Lens

Intervention Type DEVICE

Any reusable spherical silicone hydrogel brand that is approved and marketed in the country conducting the study.

Interventions

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ACUVUE® OASYS with Transitions™

JJVC Marketed Contact Lens

Intervention Type DEVICE

Silicone Hydrogel Contact Lens

Any reusable spherical silicone hydrogel brand that is approved and marketed in the country conducting the study.

Intervention Type DEVICE

Other Intervention Names

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TEST Lens CONTROL Lens

Eligibility Criteria

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Inclusion Criteria

\- Potential subjects must satisfy all of the following criteria to be enrolled in the study:

* Contact lens neophytes or those who have recently (i.e. within last 2 months) begun the use of a new lens type and have purchased a supply of lenses.
* A minimum age of 18 years, with no maximum age.
* The registrant must read and sign the Informed Consent form.
* The registrant must appear able and willing to adhere to the instructions set forth in this clinical protocol.

Exclusion Criteria

\- Potential subjects who meet any of the following criteria will be excluded from participating in the study:

* Current participant in another research study.
* Employee or relative of site, or family member of Recruiting Practitioner or Johnson \& Johnson.
* Non-spherical contact lens wearers, i.e. toric or multifocal lenses.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Johnson & Johnson Vision Care, Inc Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Vision Care, Inc.

Locations

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Sanchez Rubal Ltd. - Sanchez Bregua

A Coruña, , Spain

Site Status

Sanchez Rubal Ltd - Finisterre

A Coruña, , Spain

Site Status

Optica Ronda

Almería, , Spain

Site Status

Natural Optics Balaguer

Balaguer, , Spain

Site Status

Centro Optico Raga

Linares, , Spain

Site Status

Centro Optico Montero

Madrid, , Spain

Site Status

Centro Boston de Optometria

Madrid, , Spain

Site Status

Cirugia Ocular de Madrid

Madrid, , Spain

Site Status

Opticalia Real Villa

Madrid, , Spain

Site Status

Opticas ClaraVision

Ontinyent, , Spain

Site Status

Centro Optico

Seville, , Spain

Site Status

Eyesite Opticians

Reading, Berkshire, United Kingdom

Site Status

Leightons Insight Marlow

Marlow, Buckinghamshire, United Kingdom

Site Status

P Shah Opticians

London, England, United Kingdom

Site Status

Eyes On the Common Ltd.

London, England, United Kingdom

Site Status

Hodd Barnes Dickens Ltd

London, England, United Kingdom

Site Status

Eyesite Opticians

Winchester, Hampshire, United Kingdom

Site Status

First Contact Opticians Ltd.

Eastcote, Middlesex, United Kingdom

Site Status

Urquhart Opticians Ltd

Kilmarnock, Scotland, United Kingdom

Site Status

Eyesite Opticians

Weybridge, Surrey, United Kingdom

Site Status

Auckland Opticians

Horbury, Wakefield, United Kingdom

Site Status

Chalmers Opticians Ltd

Cardiff, Wales, United Kingdom

Site Status

Countries

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Spain United Kingdom

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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CR-6334

Identifier Type: -

Identifier Source: org_study_id

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