Vision Satisfaction in Bright LightNCT04116736
ACUVUE® OASYS With Transitions™ Light Intelligent Technology™ Clinical Performance Registry
An observational study of Vision Satisfaction in Bright Light, run by Johnson & Johnson Vision Care, Inc. at 22 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vision Satisfaction in Bright Light
- What is being tested?
- ACUVUE® OASYS with Transitions™ and Silicone Hydrogel Contact Lens
- Type of treatment
- Medical device
- How many people
- 146 participants
- Where
- 22 sitesin 2 countries
- Study dates
- 19 Oct 2019to 10 Mar 2023
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
22 sites in 2 countries.
22 sites in 2 countries
Spain11 sites
Sanchez Rubal Ltd. - Sanchez Bregua
A Coruña, 15004
Sanchez Rubal Ltd - Finisterre
A Coruña, 15005
Optica Ronda
Almería, 04009
Natural Optics Balaguer
Balaguer, 25600
Centro Optico Raga
Linares, 23700
Centro Optico Montero
Madrid, 20832
Centro Boston de Optometria
Madrid, 28010
Cirugia Ocular de Madrid
Madrid, 28015
Opticalia Real Villa
Madrid, 28600
Opticas ClaraVision
Ontinyent, 46870
Centro Optico
Seville, 41702
United Kingdom11 sites
Chalmers Opticians Ltd
Cardiff, Wales, CF243RQ
First Contact Opticians Ltd.
Eastcote, Middlesex, HA5 1RJ
Auckland Opticians
Horbury, Wakefield, WF4 5AB
Urquhart Opticians Ltd
Kilmarnock, Scotland, KA1 2BS
P Shah Opticians
London, England, EC1V 2NP
Eyes On the Common Ltd.
London, England, W5 3LD
Hodd Barnes Dickens Ltd
London, England, WC1V 6LF
Leightons Insight Marlow
Marlow, Buckinghamshire, SL7 1AE
Eyesite Opticians
Reading, Berkshire, RG1 1EX
Eyesite Opticians
Weybridge, Surrey, KT13 8DL
Eyesite Opticians
Winchester, Hampshire, SO23 9BX
About this study
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
- Being tested
- ACUVUE® OASYS with Transitions™, Silicone Hydrogel Contact Lens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACUVUE® OASYS with Transitions™Device
Also called TEST Lens
JJVC Marketed Contact Lens
Silicone Hydrogel Contact LensDevice
Also called CONTROL Lens
Any reusable spherical silicone hydrogel brand that is approved and marketed in the country conducting the study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Silicone Hydrogel Contact Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 12-month questionnaire follow-up
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Throughout the duration of the study, up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2019
- Study start19 Oct 2019
- Primary completion10 Mar 2023
- Study completion10 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vision Satisfaction in Bright LightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 146 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Vision Care, Inc Clinical Trial, Study director, Johnson & Johnson Vision Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04116736
- Sponsor's protocol ID
- CR-6334
- Status last verified
- May 2025
- First submitted
- 3 Oct 2019
- Last updated
- 23 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACUVUE® OASYS With Transitions™ Light Intelligent Technology™ Clinical Performance Registry
- ClinicalTrials.gov ID
- NCT04116736
- Acronym / sponsor ID
- CR-6334
- Conditions
- Vision Satisfaction in Bright Light
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Oct 2019 (actual)
- Primary completion
- 10 Mar 2023 (actual)
- Study completion
- 10 Mar 2023 (actual)
- First posted
- 7 Oct 2019 (actual)
- Results
- Posted 23 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEST Lens | – | Device: ACUVUE® OASYS with Transitions™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. |
| CONTROL Lens | – | Device: Silicone Hydrogel Contact LensEligible 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACUVUE® OASYS with Transitions™Also: TEST LensJJVC Marketed Contact Lens | Device | TEST Lens |
| Silicone Hydrogel Contact LensAlso: CONTROL LensAny reusable spherical silicone hydrogel brand that is approved and marketed in the country conducting the study. | Device | CONTROL Lens |
Primary outcome
Vision Satisfaction in Bright Lighting - 2-Week Questionnaire
Time frame: 2-week questionnaire follow-up
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.
Vision Satisfaction in Bright Lighting - 4-Month Questionnaire
Time frame: 4-month questionnaire follow-up
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.
Vision Satisfaction in Bright Lighting - 12-Month Questionnaire
Time frame: 12-month questionnaire follow-up
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.
8 secondary outcomes
Overall Quality of Vision - 2-Week Questionnaire
Time frame: 2-week questionnaire follow-up
Overall Quality of Vision - 4-Month Questionnaire
Time frame: 4-month questionnaire follow-up
Overall Quality of Vision - 12-Month Questionnaire
Time frame: 12-month questionnaire follow-up
Overall Comfort - 2-Week Questionnaire
Time frame: 2-week questionnaire follow-up
Overall Comfort - 4-Month Questionnaire
Time frame: 4-month questionnaire follow-up
Overall Comfort - 12-Month Questionnaire
Time frame: 12-month questionnaire follow-up
Pulfrich Effect
Time frame: 2-week, 4-month, and 12-month questionnaire follow-up
Serious or Significant Adverse Events
Time frame: Throughout the duration of the study, up to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnson & Johnson Vision Care, Inc Clinical Trial study director
Johnson & Johnson Vision Care, Inc.
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vision Satisfaction in Bright Light, run by Johnson & Johnson Vision Care, Inc. at 22 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vision Satisfaction in Bright Lighting - 2-Week Questionnaire (time frame: 2-week questionnaire follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.