Visual AcuityNCT04287036
Objective Vision Evaluation of Two Cosmetic Contact Lenses
A study testing JJVC Investigational Contact Lens and 1-DAY ACUVUE® DEFINE® Radiant Sweet™ in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 1 site in United States.
Trial summary
This is a single visit, single site, brand-masked, non-dispensing, 2×2 bilateral crossover study. Each subject will be bilaterally fitted with one of the two test articles in each of the study periods. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Acuity
- What is being tested?
- JJVC Investigational Contact Lens and 1-DAY ACUVUE® DEFINE® Radiant Sweet™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2020to 26 Feb 2020
- Phase
- Interventional
- 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 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Potential subjects must satisfy all of the following criteria to be enrolled in the study:
- The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form
- Appear able and willing to adhere to the instructions set forth in this clinical protocol.
- Subjects between 18 and 39 (inclusive) years of age at the time of screening
- Be a current soft contact lens wearer in both eyes with a minimum of 6 hours/day and 5 days/week over the last month by self-report.
- The subject must be willing to be photographed and/or video-taped.
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- The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 D to -5.00 D (inclusive) in each eye
- The subject's refractive cylinder must be less than or equal to 0.75 D (inclusive) in each eye
- Have spherical best corrected visual acuity of 20/25 or better in each eye.
Who cannot join
- Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- Currently pregnant or lactating
- Any systemic disease (eg, Sjögren's Syndrome), allergies, infectious disease (eg, hepatitis, tuberculosis), contagious immunosuppressive diseases (eg, HIV), autoimmune disease (eg rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study (at the investigators discretion).
- Use of systemic medications (eg, chronic steroid use) that are known to interfere with contact lens wear (at the investigators discretion).
- Any previous or planned (during the study) ocular surgery (eg, radial keratotomy, PRK, LASIK, etc.).
- Participation in any contact lens or lens care product clinical trial within seven (7) days prior to study enrollment
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- Employee or family members of clinical site (eg, Investigator, Coordinator, Technician).
- Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion (at the investigators discretion).
- Clinically significant (Grade 3 or 4 on FDA scale) tarsal abnormalities, bulbar injection, corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
Trial locations and contacts
1 site in 1 country.
About this study
This is a single visit, single site, brand-masked, non-dispensing, 2×2 bilateral crossover study. Each subject will be bilaterally fitted with one of the two test articles in each of the study periods.
- Conditions
- Visual Acuity
- Being tested
- JJVC Investigational Contact Lens, 1-DAY ACUVUE® DEFINE® Radiant Sweet™
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JJVC Investigational Contact LensDevice
TEST
1-DAY ACUVUE® DEFINE® Radiant Sweet™Device
CONTROL
| Study group | Role | What they receive |
|---|---|---|
| Test/Control | Experimental | Eligible Subjects aged 18 to 39 years (inclusive) who are habitual soft contact lens wearers will be randomized into sequence, Test/Control Receives: Device: JJVC Investigational Contact Lens; Device: 1-DAY ACUVUE® DEFINE® Radiant Sweet™ |
| Control/Test | Experimental | Eligible Subjects aged 18 to 39 years (inclusive) who are habitual soft contact lens wearers will be randomized into sequence, Control/Test. Receives: Device: JJVC Investigational Contact Lens; Device: 1-DAY ACUVUE® DEFINE® Radiant Sweet™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance Binocular Visual Acuity (logMAR)
Visual acuity on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4 meters) under high luminance high contrast, high luminance low contrast and low luminance high contrast with distance goggles using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. Letter-by-letter results calculated the visual performance score for each chart read. logMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR value of 0.0 is equivalent to 20/20 Snellen vision.
Measured: 20- Minutes Post-Lens Fitting
Near BinocularVisual Acuity (logMAR)
Visual acuity on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at near (40 cm) under High luminance low contrast and low luminance high contrast with distance goggles using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. Letter-by-letter results calculated the visual performance score for each chart read. logMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR value of 0.0 is equivalent to 20/20 Snellen vision.
Measured: 20- Minutes Post-Lens Fitting
Quantitative Visual Acuity
Quantitative Visual Acuity (qVA) was measured at distance (4 meter) under low room illumination (4 lux), low luminance, high contrast conditions in the right eye only and in both eyes using AST Sentio vision Testing System. During testing 25 triplets of test letters were displayed on a large stationary monitor (118 CM), the operator recorded the patient's responses using the remote (Android Tablet). After a testing session had been completed the software calculated the VA threshold. VA threshold was defined as the logMAR stimulus size at which the expected probability of correct letter identification is 66%. when both eyes are measured. The average median VA threshold was reported for each lens. Lower values indicate better vision.
Measured: 20- Minutes Post-Lens Fitting
Area Under Contrast Sensitivity Function Curve
Area under the log Curve was measured at 1.5, 3, 6, 12 and 18 cycles per degree (cpd) in the right eye only and in both eyes using AST Sentio vision Testing System. During testing 25 triplets of test letters were displayed on a large stationary monitor (118 CM), the operator recorded the patient's responses using the remote (Android Tablet). After a testing session had been completed the software calculated the Area under the log contrast sensitivity function from 1.5 cpd to 18 cpd. The average area under the log curve was reported for each lens. Higher values indicate better vision. Number of eyes is 50 when both eyes are measured.
Measured: 20- Minutes Post-Lens Fitting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start12 Feb 2020
- Primary completion26 Feb 2020
- Study completion26 Feb 2020
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 Visual AcuityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04287036
- Sponsor's protocol ID
- CR-6396
- Status last verified
- Apr 2025
- First submitted
- 25 Feb 2020
- Last updated
- 27 Apr 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 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Vision Evaluation of Two Cosmetic Contact Lenses
- ClinicalTrials.gov ID
- NCT04287036
- Acronym / sponsor ID
- CR-6396
- Conditions
- Visual Acuity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Feb 2020 (actual)
- Primary completion
- 26 Feb 2020 (actual)
- Study completion
- 26 Feb 2020 (actual)
- First posted
- 27 Feb 2020 (actual)
- Results
- Posted 3 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single visit, single site, brand-masked, non-dispensing, 2×2 bilateral crossover study. Each subject will be bilaterally fitted with one of the two test articles in each of the study periods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test/Control | Experimental | Device: JJVC Investigational Contact Lens, Device: 1-DAY ACUVUE® DEFINE® Radiant Sweet™Eligible Subjects aged 18 to 39 years (inclusive) who are habitual soft contact lens wearers will be randomized into sequence, Test/Control |
| Control/Test | Experimental | Device: JJVC Investigational Contact Lens, Device: 1-DAY ACUVUE® DEFINE® Radiant Sweet™Eligible Subjects aged 18 to 39 years (inclusive) who are habitual soft contact lens wearers will be randomized into sequence, Control/Test. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Potential subjects must satisfy all of the following criteria to be enrolled in the study:
Key exclusion criteria (9 listed)
- Potential subjects who meet any of the following criteria will be excluded from participating in the study:
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 |
|---|---|---|
| JJVC Investigational Contact LensTEST | Device | Control/Test, Test/Control |
| 1-DAY ACUVUE® DEFINE® Radiant Sweet™CONTROL | Device | Control/Test, Test/Control |
Primary outcome
Distance Binocular Visual Acuity (logMAR)
Time frame: 20- Minutes Post-Lens Fitting
Visual acuity on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4 meters) under high luminance high contrast, high luminance low contrast and low luminance high contrast with distance goggles using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. Letter-by-letter results calculated the visual performance score for each chart read. logMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR value of 0.0 is equivalent to 20/20 Snellen vision.
Near BinocularVisual Acuity (logMAR)
Time frame: 20- Minutes Post-Lens Fitting
Visual acuity on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at near (40 cm) under High luminance low contrast and low luminance high contrast with distance goggles using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. Letter-by-letter results calculated the visual performance score for each chart read. logMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR value of 0.0 is equivalent to 20/20 Snellen vision.
Quantitative Visual Acuity
Time frame: 20- Minutes Post-Lens Fitting
Quantitative Visual Acuity (qVA) was measured at distance (4 meter) under low room illumination (4 lux), low luminance, high contrast conditions in the right eye only and in both eyes using AST Sentio vision Testing System. During testing 25 triplets of test letters were displayed on a large stationary monitor (118 CM), the operator recorded the patient's responses using the remote (Android Tablet). After a testing session had been completed the software calculated the VA threshold. VA threshold was defined as the logMAR stimulus size at which the expected probability of correct letter identification is 66%. when both eyes are measured. The average median VA threshold was reported for each lens. Lower values indicate better vision.
Area Under Contrast Sensitivity Function Curve
Time frame: 20- Minutes Post-Lens Fitting
Area under the log Curve was measured at 1.5, 3, 6, 12 and 18 cycles per degree (cpd) in the right eye only and in both eyes using AST Sentio vision Testing System. During testing 25 triplets of test letters were displayed on a large stationary monitor (118 CM), the operator recorded the patient's responses using the remote (Android Tablet). After a testing session had been completed the software calculated the Area under the log contrast sensitivity function from 1.5 cpd to 18 cpd. The average area under the log curve was reported for each lens. Higher values indicate better vision. Number of eyes is 50 when both eyes are measured.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 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
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JJVC Investigational Contact Lens and 1-DAY ACUVUE® DEFINE® Radiant Sweet™ in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 1 site in United States.
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 9 inclusion and 9 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 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 3 May 2021). 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?
Distance Binocular Visual Acuity (logMAR) (time frame: 20- Minutes Post-Lens Fitting). The study lists 4 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 27 Apr 2025.