Visual AcuityNCT05120128
Changes in Inflammatory Biomarkers When Symptomatic Contact Lens Wearers Are Refit in Acuvue Oasys 1-Day Lenses
A study testing Acuvue® Oasys 1-Day in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 1 site in United Kingdom.
Trial summary
This is a 5-Visit, single-arm, single-site, subject masked, dispensing trial to evaluate contact lens discomfort and inflammatory biomarker expression. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Acuity
- What is being tested?
- Acuvue® Oasys 1-Day
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Nov 2021to 13 Dec 2022
- 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 60 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:
- 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.
- Be between 18 and 60 (inclusive) years of age at the time of screening.
- By self-report, habitually wear one of four soft spherical contact lens types (1-Day Acuvue Moist, Dailies Aqua Comfort Plus, Dailies Total1, Clariti 1 Day) in both eyes in a daily disposable wear modality. Habitual wear is defined as a minimum of 8 hours of wear per day, for a minimum of 4 days per week during the past 4 weeks.
- Have a CLDEQ-8 score at pre-screening of 15 or more.
Show all 10Show fewer
- Own a wearable pair of spectacles.
- The habitual contact lens sphere correction in each eye must be between -6.00 and -0.50 D or between +0.50 and +4.00 D (inclusive).
- The magnitude of the cylinder component of the subject's distance over-refraction must be 1.00 DC or less in each eye.
- The subject must have visual acuity of 0.2 high contrast logMAR or better with spherocylinder over-refraction in each eye.
Who cannot join
- Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- Be currently pregnant or breastfeeding
- By self-report, have any ocular or systemic disease, allergies, infection, or use of medication that might contraindicate or interfere with contact lens wear, or otherwise compromise study endpoints, including infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus [HIV]), autoimmune disease (e.g. rheumatoid arthritis, Sjögren's syndrome), or history of serious mental illness or seizures. See Section 9.1 for additional details regarding excluded systemic medications.
- Have had any previous ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, cataract etc.).
- Habitually wear multi-focal, toric, or extended wear contact lens correction
- Have participated in any contact lens or lens care product clinical trial within 14 days prior to study enrollment
Show all 11Show fewer
- Be an employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician)
- Have a history of amblyopia or strabismus.
- Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (eg. SynergEyes) within the past 6 months.
- Have clinically significant (grade 3 or higher on the Efron grading scale) slit lamp findings (e.g., corneal edema or neovascularization, conjunctival or limbal redness) or any other abnormality which would normally contraindicate contact lens wear
- Have any ocular infection.
Trial locations and contacts
1 site in 1 country.
About this study
This is a 5-Visit, single-arm, single-site, subject masked, dispensing trial to evaluate contact lens discomfort and inflammatory biomarker expression.
Read the detailed description
The study will assess device feasibility for up to 10 habitual wearers of 4 different types of marketed contact lens.
- Conditions
- Visual Acuity
- Being tested
- Acuvue® Oasys 1-Day
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acuvue® Oasys 1-DayDevice
TEST Lens
| Study group | Role | What they receive |
|---|---|---|
| TEST Lens | Experimental | Eligible subjects who are habitual soft contact lens wearers will enter wearing their own lens, then given the TEST Lens for the remainder of the study. Receives: Device: Acuvue® Oasys 1-Day |
What is being measured
The primary outcome is the main question the study is designed to answer.
CLDEQ-8 Score follow up 1
Correlation between change in CLDEQ-8 score and change in MMP-9 biomarker expression
Measured: at 1-week follow-up
CLDEQ-8 Score follow up 2
Correlation between change in CLDEQ-8 score and change in MMP-9 biomarker expression
Measured: at 2-week follow-up
MMP-9 Expression in Epithelial Cells of Bulbar Conjunctiva
Each subject will have EyeprimTM samples collected which involves the 'double impression' technique where samples are collected twice from the same location using a single EyeprimTM membrane. Samples will be collected from the temporal bulbar conjunctiva in both eyes. From these samples, biomarker expression for MMP-9 will be measured. A higher level of MMP-9 expression is associated with a stronger inflammatory response.
Measured: at 1-week follow-up
MMP-9 Expression in Epithelial Cells of Upper Eyelid Wiper
Each subject will have EyeprimTM samples collected which involves the 'double impression' technique where samples are collected twice from the same location using a single EyeprimTM membrane. Samples will be collected from the upper lid margin in both eyes. From these samples, biomarker expression for MMP-9 will be measured. A higher level of MMP-9 expression is associated with a stronger inflammatory response.
Measured: at 1-week follow-up
MMP-9 Expression in Epithelial Cells of Bulbar Conjunctiva
Each subject will have EyeprimTM samples collected which involves the 'double impression' technique where samples are collected twice from the same location using a single EyeprimTM membrane. Samples will be collected from the temporal bulbar conjunctiva in both eyes. From these samples, biomarker expression for MMP-9 will be measured. A higher level of MMP-9 expression is associated with a stronger inflammatory response.
Measured: at 2-week follow-up
MMP-9 Expression in Epithelial Cells of Upper Eyelid Wiper
Each subject will have EyeprimTM samples collected which involves the 'double impression' technique where samples are collected twice from the same location using a single EyeprimTM membrane. Samples will be collected from the upper lid margin in both eyes. From these samples, biomarker expression for MMP-9 will be measured. A higher level of MMP-9 expression is associated with a stronger inflammatory response.
Measured: at 2-week follow-up
Secondary outcomes (3)
Average difference in CLDEQ-8 scores between Subjects' own lens and AO1D
CLDEQ-8 is a validated outcome measure for soft contact lens wearers. It has been highly correlated with habitual baseline status and change in overall opinion when subjects are refit with contact lenses.10 The sum of the item scores of CLDEQ-8, ranging from 0 to 37, will be used to assess dry eye symptoms, where higher scores indicated more serious symptoms. The score will be calculated for each group (subject's own lens and AO1D) and timepoint (1- and 2-week follow-up). The difference between subjects' own lens and AO1D will be calculated as (AO1D minus subjects' own lens). The average will be reported for each timepoint.
Measured: up to 2-week follow-up
Average Difference in MMP-9 Expression in Epithelial Cells of Bulbar Conjuctiva between Subjects' own lens and AO1D
Each subject will have EyeprimTM samples collected which involves the 'double impression' technique where samples are collected twice from the same location using a single EyeprimTM membrane. Samples will be collected from the temporal bulbar conjuctiva in both eyes. From these samples, biomarker expression for MMP-9 will be measured. A higher level of MMP-9 expression is associated with a stronger inflammatory response. The score will be measured for each group (subject's own lens and AO1D) and timepoint (1- and 2-week follow-up). The difference between subjects' own lens and AO1D will be measured as (AO1D minus subjects' own lens). The average difference will be reported for each timepoint.
Measured: up to 2 week follow up
Average Difference in MMP-9 Expression in Epithelial Cells of Upper Eyelid Wiper between Subjects' own lens and AO1D
Each subject will have EyeprimTM samples collected which involves the 'double impression' technique where samples are collected twice from the same location using a single EyeprimTM membrane. Samples will be collected from the upper lid margin in both eyes. From these samples, biomarker expression for MMP-9 will be measured. A higher level of MMP-9 expression is associated with a stronger inflammatory response. The score will be measured for each group (subject's own lens and AO1D) and timepoint (1- and 2-week follow-up). The difference between subjects' own lens and AO1D will be measured as (AO1D minus subjects' own lens). The average difference will be reported for each timepoint.
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 posted15 Nov 2021
- Study start24 Nov 2021
- Primary completion13 Dec 2022
- Study completion13 Dec 2022
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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
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
- NCT05120128
- Sponsor's protocol ID
- CR-6433
- Status last verified
- Nov 2023
- First submitted
- 3 Nov 2021
- Last updated
- 8 Nov 2023
- 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 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Inflammatory Biomarkers When Symptomatic Contact Lens Wearers Are Refit in Acuvue Oasys 1-Day Lenses
- ClinicalTrials.gov ID
- NCT05120128
- Acronym / sponsor ID
- CR-6433
- Conditions
- Visual Acuity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Nov 2021 (actual)
- Primary completion
- 13 Dec 2022 (actual)
- Study completion
- 13 Dec 2022 (actual)
- First posted
- 15 Nov 2021 (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 5-Visit, single-arm, single-site, subject masked, dispensing trial to evaluate contact lens discomfort and inflammatory biomarker expression.
Detailed description
The study will assess device feasibility for up to 10 habitual wearers of 4 different types of marketed contact lens.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TEST Lens | Experimental | Device: Acuvue® Oasys 1-DayEligible subjects who are habitual soft contact lens wearers will enter wearing their own lens, then given the TEST Lens for the remainder of the study. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Potential subjects must satisfy all of the following criteria to be enrolled in the study:
Key exclusion criteria (11 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 |
|---|---|---|
| Acuvue® Oasys 1-DayTEST Lens | Device | TEST Lens |
Primary outcome
CLDEQ-8 Score follow up 1
Time frame: at 1-week follow-up
Correlation between change in CLDEQ-8 score and change in MMP-9 biomarker expression
CLDEQ-8 Score follow up 2
Time frame: at 2-week follow-up
Correlation between change in CLDEQ-8 score and change in MMP-9 biomarker expression
MMP-9 Expression in Epithelial Cells of Bulbar Conjunctiva
Time frame: at 1-week follow-up
Each subject will have EyeprimTM samples collected which involves the 'double impression' technique where samples are collected twice from the same location using a single EyeprimTM membrane. Samples will be collected from the temporal bulbar conjunctiva in both eyes. From these samples, biomarker expression for MMP-9 will be measured. A higher level of MMP-9 expression is associated with a stronger inflammatory response.
MMP-9 Expression in Epithelial Cells of Upper Eyelid Wiper
Time frame: at 1-week follow-up
Each subject will have EyeprimTM samples collected which involves the 'double impression' technique where samples are collected twice from the same location using a single EyeprimTM membrane. Samples will be collected from the upper lid margin in both eyes. From these samples, biomarker expression for MMP-9 will be measured. A higher level of MMP-9 expression is associated with a stronger inflammatory response.
MMP-9 Expression in Epithelial Cells of Bulbar Conjunctiva
Time frame: at 2-week follow-up
Each subject will have EyeprimTM samples collected which involves the 'double impression' technique where samples are collected twice from the same location using a single EyeprimTM membrane. Samples will be collected from the temporal bulbar conjunctiva in both eyes. From these samples, biomarker expression for MMP-9 will be measured. A higher level of MMP-9 expression is associated with a stronger inflammatory response.
MMP-9 Expression in Epithelial Cells of Upper Eyelid Wiper
Time frame: at 2-week follow-up
Each subject will have EyeprimTM samples collected which involves the 'double impression' technique where samples are collected twice from the same location using a single EyeprimTM membrane. Samples will be collected from the upper lid margin in both eyes. From these samples, biomarker expression for MMP-9 will be measured. A higher level of MMP-9 expression is associated with a stronger inflammatory response.
3 secondary outcomes
Average difference in CLDEQ-8 scores between Subjects' own lens and AO1D
Time frame: up to 2-week follow-up
Average Difference in MMP-9 Expression in Epithelial Cells of Bulbar Conjuctiva between Subjects' own lens and AO1D
Time frame: up to 2 week follow up
Average Difference in MMP-9 Expression in Epithelial Cells of Upper Eyelid Wiper between Subjects' own lens and AO1D
Time frame: up to 2 week follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- 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
Related trials for Visual Acuity
Recruiting
Comparison of ACUVUE® OASYS MAX 1-Day Multifocal and DAILIES® AquaComfort Plus® Multifocal
Visual Acuity
Active, not recruiting
Evaluation of Approved Contact Lenses (CR-6657)
Visual Acuity
RecruitingPhase 3
Study to Assess the Injection Burden, Adverse Events, Change in Disease Activity, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD)
Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 2
Safety and Efficacy of ADVM-022 in Treatment-Experienced Patients With Neovascular Age-related Macular Degeneration [LUNA]
Neovascular Age-related Macular Degeneration
RecruitingPhase 3
Intravitreal Faricimab Injections or Fluocinolone Acetonide (0.19 mg) Intravitreal Implants vs Observation for Prevention of VA Loss Due to Radiation Retinopathy
Radiation Retinopathy, Visual Impairment
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acuvue® Oasys 1-Day in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 1 site in United Kingdom.
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 10 inclusion and 11 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 8 Nov 2023. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
CLDEQ-8 Score follow up 1 (time frame: at 1-week follow-up). The study lists 6 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 8 Nov 2023.