Visual AcuityNCT05344560
Evaluation of Toric Soft Contact Lenses Containing a Chromophore to Block High-Energy Visible Light
A study testing soft contact lens in senofilcon A (C3) with HEVL-blocking chromophore and ACUVUE OASYS 1-Day for Astigmatism in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 10 sites in United States.
Trial summary
This will be a 4-visit, randomized, controlled, single-masked, bilateral wear, dispensing, 2-treament, 2-sequence, 3-period crossover study to evalulate overall vision and comfort.. 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?
- soft contact lens in senofilcon A (C3) with HEVL-blocking chromophore and ACUVUE OASYS 1-Day for Astigmatism
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 10 sitesUnited States
- Study dates
- 9 May 2022to 9 Aug 2022
- 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 of all 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 39 years of age (inclusive) at the time of screening.
- By self-report, habitually wear soft contact lenses in both eyes in a daily or daily disposable wear modality (i.e. not extended wear modality). Habitual wearer is defined as a minimum of 6 hours per day, for a minimum of 2 days per week during the past four weeks.
- Possess a wearable pair of spectacles that provide correction for distance vision.
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- In both eyes, have refractive error suitable for correction with the toric contact lens powers available in this study:
- Sphere powers (DS) -1.50 through -4.00 in 0.25 steps
- Cylinder powers (DC) -0.75 and -1.25
- Axes (degrees) 170, 180, 10, 80, 90, 100
- Have best corrected monocular distance visual acuity of 20/30 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:
- Be currently pregnant or lactating.
- Be diabetic.
- Be currently using any ocular medications or have an ocular infection of any type.
- 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.
- Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months.
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- Be currently wearing monovision or multifocal contact lenses.
- Be currently wearing lenses in an extended wear modality.
- Have a history of strabismus or amblyopia.
- Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an employee (including partner, child, parent, grandparent, grandchild or sibling of the employee or their spouse) of the clinical site.
- Have participated in a contact lens or lens care product clinical trial within 7 days prior to study enrollment.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
ProCare Vision Centers
Granville, Ohio, 43023
Dr. James Weber & Associates, PA - City Square Blvd
Jacksonville, Florida, 32218
Stam & Associates Eye Care
Jacksonville, Florida, 32256
Sabal Eye Care
Longwood, Florida, 32779
Maitland Vision Center - North Orlando Ave
Maitland, Florida, 32751
Optometry Group, LLC
Memphis, Tennessee, 38111
Southwest Orlando Eye Care
Orlando, Florida, 32819
Kannarr Eye Care
Pittsburg, Kansas, 66762
Tyler Eye Associates
Tyler, Texas, 75703
Dr. David W. Ferris & Associates
Warwick, Rhode Island, 02888
About this study
Official title: Evaluation of Toric Soft Contact Lenses Containing a Chromophore to Block High-Energy Visible Light Produced on Commercial Manufacturing Lines
This will be a 4-visit, randomized, controlled, single-masked, bilateral wear, dispensing, 2-treament, 2-sequence, 3-period crossover study to evalulate overall vision and comfort..
- Conditions
- Visual Acuity
- Being tested
- soft contact lens in senofilcon A (C3) with HEVL-blocking chromophore, ACUVUE OASYS 1-Day for Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
soft contact lens in senofilcon A (C3) with HEVL-blocking chromophoreDevice
TEST Lens
ACUVUE OASYS 1-Day for AstigmatismDevice
CONTROL Lens
| Study group | Role | What they receive |
|---|---|---|
| test/control/control | Experimental | Eligible subjects that are habitual contact lens wearers will be randomized into the (test/control/control) sequence and will wear two different study lenses one at a time bilaterally over three wear periods. Receives: Device: soft contact lens in senofilcon A (C3) with HEVL-blocking chromophore; Device: ACUVUE OASYS 1-Day for Astigmatism |
| control/test/test | Experimental | Eligible subjects that are habitual contact lens wearers will be randomized into the (control/test/test) sequence and will wear two different study lenses one at a time bilaterally over three wear periods. Receives: Device: soft contact lens in senofilcon A (C3) with HEVL-blocking chromophore; Device: ACUVUE OASYS 1-Day for Astigmatism |
What is being measured
The primary outcome is the main question the study is designed to answer.
CLUE Comfort Score
Subjective comfort was assessed using Contact Lens User Experience (CLUE) questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (Comfort, Vision, Handling, and Packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution where scores range from 0 to 120 with a population average score of 60 (SD 20). Higher CLUE scores indicate a more favorable/positive response. The average CLUE comfort score was report for each lens type.
Measured: 1-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 posted25 Apr 2022
- Study start9 May 2022
- Primary completion9 Aug 2022
- Study completion9 Aug 2022
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
- 126 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
- NCT05344560
- Sponsor's protocol ID
- CR-6484
- Status last verified
- Sep 2023
- First submitted
- 19 Apr 2022
- Last updated
- 15 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- 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 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Toric Soft Contact Lenses Containing a Chromophore to Block High-Energy Visible Light Produced on Commercial Manufacturing Lines
- ClinicalTrials.gov ID
- NCT05344560
- Acronym / sponsor ID
- CR-6484
- Conditions
- Visual Acuity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 May 2022 (actual)
- Primary completion
- 9 Aug 2022 (actual)
- Study completion
- 9 Aug 2022 (actual)
- First posted
- 25 Apr 2022 (actual)
- Results
- Posted 15 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a 4-visit, randomized, controlled, single-masked, bilateral wear, dispensing, 2-treament, 2-sequence, 3-period crossover study to evalulate overall vision and comfort..
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test/control/control | Experimental | Device: soft contact lens in senofilcon A (C3) with HEVL-blocking chromophore, Device: ACUVUE OASYS 1-Day for AstigmatismEligible subjects that are habitual contact lens wearers will be randomized into the (test/control/control) sequence and will wear two different study lenses one at a time bilaterally over three wear periods. |
| control/test/test | Experimental | Device: soft contact lens in senofilcon A (C3) with HEVL-blocking chromophore, Device: ACUVUE OASYS 1-Day for AstigmatismEligible subjects that are habitual contact lens wearers will be randomized into the (control/test/test) sequence and will wear two different study lenses one at a time bilaterally over three wear periods. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Potential subjects must satisfy of all 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 39 years of age (inclusive) at the time of screening.
- By self-report, habitually wear soft contact lenses in both eyes in a daily or daily disposable wear modality (i.e. not extended wear modality). Habitual wearer is defined as a minimum of 6 hours per day, for a minimum of 2 days per week during the past four weeks.
Key exclusion criteria (11 listed)
- Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- Be currently pregnant or lactating.
- Be diabetic.
- Be currently using any ocular medications or have an ocular infection of any type.
- 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.
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 |
|---|---|---|
| soft contact lens in senofilcon A (C3) with HEVL-blocking chromophoreTEST Lens | Device | control/test/test, test/control/control |
| ACUVUE OASYS 1-Day for AstigmatismCONTROL Lens | Device | control/test/test, test/control/control |
Primary outcome
CLUE Comfort Score
Time frame: 1-Week Follow-up
Subjective comfort was assessed using Contact Lens User Experience (CLUE) questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (Comfort, Vision, Handling, and Packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution where scores range from 0 to 120 with a population average score of 60 (SD 20). Higher CLUE scores indicate a more favorable/positive response. The average CLUE comfort score was report for each lens type.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- 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.
Johnson & Johnson Vision Care, Inc. Clinical Trial study director
Johnson & Johnson Vision Care, Inc.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing soft contact lens in senofilcon A (C3) with HEVL-blocking chromophore and ACUVUE OASYS 1-Day for Astigmatism in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 10 sites 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 11 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 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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 15 Sep 2023). 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?
CLUE Comfort Score (time frame: 1-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 15 Sep 2023.