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

NCT04116736 | Completed Results FDA Device

• 1 other identifier: CR-6334
• Study Type: observational
• Target: 146
• Locations: 2 countries
• Sites: 22

Brief Summary

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.

Conditions

Vision Satisfaction in Bright Light

Outcome Measures

Primary Outcomes (3)

• Vision Satisfaction in Bright Lighting - 2-Week Questionnaire

  Subjects will be asked to evaluate their vision satisfaction in bright lighting by rating their level of agreement with the statement "I am satisfied with the quality of my vision in bright lighting with these contact lenses" using a 5-point agreement Likert scale (Strongly Disagree, Disagree, Neither Agree Nor Disagree, Agree, and Strongly Agree). In the Control group 4 subjects were identified as ineligible after the screening visit because they were wearing ineligible Control lenses. Therefore, only 54 subjects were included in the Control group for the primary endpoint data summary. The number of missing responses in each lens group was reported.

  2-week questionnaire follow-up

• Vision Satisfaction in Bright Lighting - 4-Month Questionnaire

  Subjects will be asked to evaluate their vision satisfaction in bright lighting by rating their level of agreement with the statement "I am satisfied with the quality of my vision in bright lighting with these contact lenses" using a 5-point agreement Likert scale (Strongly Disagree, Disagree, Neither Agree Nor Disagree, Agree, and Strongly Agree). In the Control group 4 subjects were identified as ineligible after the screening visit because they were wearing ineligible Control lenses. Therefore, only 54 subjects were included in the Control group for the primary endpoint data summary. The number of missing responses in each lens group was reported.

  4-month questionnaire follow-up

• Vision Satisfaction in Bright Lighting - 12-Month Questionnaire

  Subjects will be asked to evaluate their vision satisfaction in bright lighting by rating their level of agreement with the statement "I am satisfied with the quality of my vision in bright lighting with these contact lenses" using a 5-point agreement Likert scale (Strongly Disagree, Disagree, Neither Agree Nor Disagree, Agree, and Strongly Agree). In the Control group 4 subjects were identified as ineligible after the screening visit because they were wearing ineligible Control lenses. Therefore, only 54 subjects were included in the Control group for the primary endpoint data summary.

  12-month questionnaire follow-up

Secondary Outcomes (8)

• Overall Quality of Vision - 2-Week Questionnaire

  2-week questionnaire follow-up

• Overall Quality of Vision - 4-Month Questionnaire

  4-month questionnaire follow-up

• Overall Quality of Vision - 12-Month Questionnaire

  12-month questionnaire follow-up

• Overall Comfort - 2-Week Questionnaire

  2-week questionnaire follow-up

• Overall Comfort - 4-Month Questionnaire

  4-month questionnaire follow-up

Study Arms (2)

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.

Device: ACUVUE® OASYS with Transitions™

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.

Device: Silicone Hydrogel Contact Lens

Interventions

ACUVUE® OASYS with Transitions™ DEVICE

JJVC Marketed Contact Lens

Also known as: TEST Lens

TEST Lens

Silicone Hydrogel Contact Lens DEVICE

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

Also known as: CONTROL Lens

CONTROL Lens

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study subjects will be recruited from the clinical site's subject database and/or utilizing Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved materials. Within the sites, subjects that have received a prescription of either Intervention within the last 2 months will be invited to participate without regard to any demographic or other ocular features.

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (22)

Sanchez Rubal Ltd. - Sanchez Bregua

A Coruña, 15004, Spain

Location

Sanchez Rubal Ltd - Finisterre

A Coruña, 15005, Spain

Location

Optica Ronda

Almería, 04009, Spain

Location

Natural Optics Balaguer

Balaguer, 25600, Spain

Location

Centro Optico Raga

Linares, 23700, Spain

Location

Centro Optico Montero

Madrid, 20832, Spain

Location

Centro Boston de Optometria

Madrid, 28010, Spain

Location

Cirugia Ocular de Madrid

Madrid, 28015, Spain

Location

Opticalia Real Villa

Madrid, 28600, Spain

Location

Opticas ClaraVision

Ontinyent, 46870, Spain

Location

Centro Optico

Seville, 41702, Spain

Location

Eyesite Opticians

Reading, Berkshire, RG1 1EX, United Kingdom

Location

Leightons Insight Marlow

Marlow, Buckinghamshire, SL7 1AE, United Kingdom

Location

P Shah Opticians

London, England, EC1V 2NP, United Kingdom

Location

Eyes On the Common Ltd.

London, England, W5 3LD, United Kingdom

Location

Hodd Barnes Dickens Ltd

London, England, WC1V 6LF, United Kingdom

Location

Eyesite Opticians

Winchester, Hampshire, SO23 9BX, United Kingdom

Location

First Contact Opticians Ltd.

Eastcote, Middlesex, HA5 1RJ, United Kingdom

Location

Urquhart Opticians Ltd

Kilmarnock, Scotland, KA1 2BS, United Kingdom

Location

Eyesite Opticians

Weybridge, Surrey, KT13 8DL, United Kingdom

Location

Auckland Opticians

Horbury, Wakefield, WF4 5AB, United Kingdom

Location

Chalmers Opticians Ltd

Cardiff, Wales, CF243RQ, United Kingdom

Location

Results Point of Contact

• Title: Graeme Young
• Organization: Johnson & Johnson Vision Care (JJVC)

g.young@visioncare.co.uk

+44(0) 1252 718719

Study Officials

• Johnson & Johnson Vision Care, Inc Clinical Trial

  Johnson & Johnson Vision Care, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2019
• First Posted: October 7, 2019
• Study Start: October 19, 2019
• Primary Completion: March 10, 2023
• Study Completion: March 10, 2023
• Last Updated: May 23, 2025
• Results First Posted: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

GB (11); ES (11)