Visual AcuityNCT04108286
Ex-vivo Adhesion of Bacteria to Different Contact Lens Materials
A study testing 1-DAY ACUVUE MOIST and DAILIES AQUA COMFORT PLUS in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc..
Trial summary
This is a single-site, 4-visit, contralateral, dispensing, open-label, randomized study. Each eligible subject will be randomized into one of two sequence groups to wear two lens types contralaterally (Test on the right eye and Control on left eye or vice versa). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Acuity
- What is being tested?
- 1-DAY ACUVUE MOIST and DAILIES AQUA COMFORT PLUS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2021to 6 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 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.
- Between 18 and 45 (inclusive) years of age at the time of screening.
- Be a current spherical soft contact lens wearer in both eyes with a minimum of 6 hours/day and 5 days/week wear time over the last 30 days by self-report.
- Have a pair of spectacles with corrected vision of 20/40 or better in each eye or uncorrected vision is 20/40 or better in each eye
- The subject's vertex-corrected spherical equivalent distance refraction must be in the range of -1.00 through -6.00 D in each eye.
- The subject has a 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 breastfeeding.
- Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
- Any autoimmune disease or use of medication, which may interfere with contact lens wear. Habitual medications used by successful soft contact lens wearers are considered acceptable.
- Any ocular abnormalities such as entropion, ectropion, extrusions, chalazia, recurrent styes, history of recurrent corneal erosions.
- Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
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- Multifocal, toric or extended wear contact lens correction.
- Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
- History of binocular vision abnormality or strabismus.
- Any infectious disease (e.g., hepatitis, tuberculosis) or contagious immunosuppressive diseases (e.g., HIV) by self-report.
- Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
- Any ocular infection.
- Any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the EFRON scale (Appendix G), any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.
- Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
About this study
This is a single-site, 4-visit, contralateral, dispensing, open-label, randomized study. Each eligible subject will be randomized into one of two sequence groups to wear two lens types contralaterally (Test on the right eye and Control on left eye or vice versa).
- Conditions
- Visual Acuity
- Being tested
- 1-DAY ACUVUE MOIST, DAILIES AQUA COMFORT PLUS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1-DAY ACUVUE MOISTDevice
Also called 1DAM
TEST
DAILIES AQUA COMFORT PLUSDevice
Also called DACP
CONTROL
| Study group | Role | What they receive |
|---|---|---|
| TEST/CONTROL | Experimental | Eligible subjects that are habitual wearers of spherical soft contact lenses will be randomly assigned to 1 of 2 contralateral lens sequences (Right: TEST/ Left: CONTROL) or (Right: CONTROL/ Left: TEST). Receives: Device: 1-DAY ACUVUE MOIST; Device: DAILIES AQUA COMFORT PLUS |
| CONTROL/TEST | Experimental | Eligible subjects that are habitual wearers of spherical soft contact lenses will be randomly assigned to 1 of 2 contralateral lens sequences (Right: TEST/ Left: CONTROL) or (Right: CONTROL/ Left: TEST). Receives: Device: 1-DAY ACUVUE MOIST; Device: DAILIES AQUA COMFORT PLUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial adhesion of clinical isolates of P. aeruginosa
Evaluation of the bacterial adhesion of 2 strains of bacteria, P. aeruginosa, on worn lenses based on the number of viable bacteria on the lens measured in colony forming unit (CFU).
Measured: up to 2-week follow-up
Secondary outcomes (1)
Uptake of Lysozyme on worn lenses
Uptake of Lysozyme on worn lenses: Evaluation of the uptake of lysozyme between different lens materials of worn lenses based on the clearance zone measured in the nearest (mm).
Measured: up to 2-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start1 Jan 2021 (estimated)
- Primary completion6 Jan 2021 (estimated)
- Study completion6 Jan 2021 (estimated)
Why it stopped: Study was withdrawn due to COVID-19 and country restrictions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 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
- NCT04108286
- Sponsor's protocol ID
- CR-6333
- Status last verified
- May 2021
- First submitted
- 26 Sep 2019
- Last updated
- 11 May 2021
- Results posted
- No
- 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 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ex-vivo Adhesion of Bacteria to Different Contact Lens Materials
- ClinicalTrials.gov ID
- NCT04108286
- Acronym / sponsor ID
- CR-6333
- Conditions
- Visual Acuity
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was withdrawn due to COVID-19 and country restrictions
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 6 Jan 2021 (estimated)
- Study completion
- 6 Jan 2021 (estimated)
- First posted
- 30 Sep 2019 (actual)
- Results
- Not posted in the source record
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-site, 4-visit, contralateral, dispensing, open-label, randomized study. Each eligible subject will be randomized into one of two sequence groups to wear two lens types contralaterally (Test on the right eye and Control on left eye or vice versa).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEST/CONTROL | Experimental | Device: 1-DAY ACUVUE MOIST, Device: DAILIES AQUA COMFORT PLUSEligible subjects that are habitual wearers of spherical soft contact lenses will be randomly assigned to 1 of 2 contralateral lens sequences (Right: TEST/ Left: CONTROL) or (Right: CONTROL/ Left: TEST). |
| CONTROL/TEST | Experimental | Device: 1-DAY ACUVUE MOIST, Device: DAILIES AQUA COMFORT PLUSEligible subjects that are habitual wearers of spherical soft contact lenses will be randomly assigned to 1 of 2 contralateral lens sequences (Right: TEST/ Left: CONTROL) or (Right: CONTROL/ Left: TEST). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Potential subjects must satisfy all of the following criteria to be enrolled in the study.
Key exclusion criteria (14 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 |
|---|---|---|
| 1-DAY ACUVUE MOISTAlso: 1DAMTEST | Device | CONTROL/TEST, TEST/CONTROL |
| DAILIES AQUA COMFORT PLUSAlso: DACPCONTROL | Device | CONTROL/TEST, TEST/CONTROL |
Primary outcome
Bacterial adhesion of clinical isolates of P. aeruginosa
Time frame: up to 2-week follow-up
Evaluation of the bacterial adhesion of 2 strains of bacteria, P. aeruginosa, on worn lenses based on the number of viable bacteria on the lens measured in colony forming unit (CFU).
1 secondary outcome
Uptake of Lysozyme on worn lenses
Time frame: up to 2-week follow-up
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing 1-DAY ACUVUE MOIST and DAILIES AQUA COMFORT PLUS in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc..
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 8 inclusion and 14 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: withdrawn, as of the sponsor's last update on 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Bacterial adhesion of clinical isolates of P. aeruginosa (time frame: up to 2-week follow-up). 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 11 May 2021.