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

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.

Study Overview

• Status: Completed
• Conditions: Vision Satisfaction in Bright Light
• Intervention / Treatment: Device: ACUVUE® OASYS with Transitions™; Device: Silicone Hydrogel Contact Lens

• Study Type: Observational
• Enrollment (Actual): 146

Contacts and Locations

Study Locations

• Spain
  • Almeria, Spain, 04009
    • Optica Ronda
  • Balaguer, Spain, 25600
    • Natural Optics Balaguer
  • La Coruna, Spain, 15004
    • Sanchez Rubal Ltd. - Sanchez Bregua
  • La Coruna, Spain, 15005
    • Sanchez Rubal Ltd - Finisterre
  • Linares, Spain, 23700
    • Centro Optico Raga
  • Madrid, Spain, 20832
    • Centro Optico Montero
  • Madrid, Spain, 28010
    • Centro Boston de Optometria
  • Madrid, Spain, 28015
    • Cirugia Ocular de Madrid
  • Madrid, Spain, 28600
    • Opticalia Real Villa
  • Ontinyent, Spain, 46870
    • Opticas ClaraVision
  • Sevilla, Spain, 41702
    • Centro Optico
• United Kingdom
  • Berkshire
    • Reading, Berkshire, United Kingdom, RG1 1EX
      • Eyesite Opticians
  • Buckinghamshire
    • Marlow, Buckinghamshire, United Kingdom, SL7 1AE
      • Leightons Insight Marlow
  • England
    • London, England, United Kingdom, EC1V 2NP
      • P Shah Opticians
    • London, England, United Kingdom, W5 3LD
      • Eyes On the Common Ltd.
    • London, England, United Kingdom, WC1V 6LF
      • Hodd Barnes Dickens Ltd
  • Hampshire
    • Winchester, Hampshire, United Kingdom, SO23 9BX
      • Eyesite Opticians
  • Middlesex
    • Eastcote, Middlesex, United Kingdom, HA5 1RJ
      • First Contact Opticians Ltd.
  • Scotland
    • Kilmarnock, Scotland, United Kingdom, KA1 2BS
      • Urquhart Opticians Ltd
  • Surrey
    • Weybridge, Surrey, United Kingdom, KT13 8DL
      • Eyesite Opticians
  • Wakefield
    • Horbury, Wakefield, United Kingdom, WF4 5AB
      • Auckland Opticians
  • Wales
    • Cardiff, Wales, United Kingdom, CF243RQ
      • Chalmers Opticians Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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™; JJVC Marketed Contact Lens; Other Names: TEST 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.	Device: Silicone Hydrogel Contact Lens; Any reusable spherical silicone hydrogel brand that is approved and marketed in the country conducting the study.; Other Names: CONTROL Lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Quality of Vision - 2-Week Questionnaire	Overall quality of vision was assessed subjectively using the item "I am satisfied with the overall quality of my vision with these contact lenses". The item used a 5-point agreement 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 this secondary endpoint data summary. The number of missing responses in each lens group was reported.	2-week questionnaire follow-up
Overall Quality of Vision - 4-Month Questionnaire	Overall quality of vision was assessed subjectively using the item "I am satisfied with the overall quality of my vision with these contact lenses". The item used a 5-point agreement 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 this secondary endpoint data summary. The number of missing responses in each lens group was reported.	4-month questionnaire follow-up
Overall Quality of Vision - 12-Month Questionnaire	Overall quality of vision was assessed subjectively using the item "I am satisfied with the overall quality of my vision with these contact lenses". The item used a 5-point agreement 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 this secondary endpoint data summary. The number of missing responses in each lens group was reported.	12-month questionnaire follow-up
Overall Comfort - 2-Week Questionnaire	Overall comfort was assessed using the item "How would you rate the overall comfort of these contact lenses?". The item used the 5-point excellence scale, Excellent, Very Good, Good, Fair, and Poor. 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 this secondary endpoint data summary. The number of missing responses in each lens group was reported.	2-week questionnaire follow-up
Overall Comfort - 4-Month Questionnaire	Overall comfort was assessed using the item "How would you rate the overall comfort of these contact lenses?". The item used the 5-point excellence scale, Excellent, Very Good, Good, Fair, and Poor. 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 this secondary endpoint data summary. The number of missing responses in each lens group was reported.	4-month questionnaire follow-up
Overall Comfort - 12-Month Questionnaire	Overall comfort was assessed using the item "How would you rate the overall comfort of these contact lenses?". The item used the 5-point excellence scale, Excellent, Very Good, Good, Fair, and Poor. 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 this secondary endpoint data summary. The number of missing responses in each lens group was reported.	12-month questionnaire follow-up
Pulfrich Effect	Pulfrich effect was assessed subjectively using the item "While wearing these lenses, my depth perception of moving objects has NOT been impacted". Subjects who disagreed or strongly disagreed with the statement were considered to have experienced the Pulfrich effect. 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 this secondary endpoint data summary.	2-week, 4-month, and 12-month questionnaire follow-up
Serious or Significant Adverse Events	A serious adverse event is any untoward medical occurrence that is potentially sight-threatening, requires hospitalization, results in persistent or significant disability / incapacity, or requires intervention to prevent permanent damage. Significant adverse events are usually symptomatic and warrant discontinuation (temporary or permanent) of the test article (excluding serious adverse events).	Throughout the duration of the study, up to 12 months

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.
• Investigators: Study Director: Johnson & Johnson Vision Care, Inc Clinical Trial, Johnson & Johnson Vision Care, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2019
• Primary Completion (Actual): March 10, 2023
• Study Completion (Actual): March 10, 2023

Study Registration Dates

• First Submitted: October 3, 2019
• First Submitted That Met QC Criteria: October 3, 2019
• First Posted (Actual): October 7, 2019

Study Record Updates

• Last Update Posted (Actual): May 23, 2025
• Last Update Submitted That Met QC Criteria: May 8, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: CR-6334

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes