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Visual AcuityNCT04869189

Non-Invasive Assessment of Contact Lens Performance During Use of a Digital Display

A study testing JJVC Marketed Contact Lens in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a two-arm, open-label, bilateral dispensing clinical investigation. Eligible subjects will proceed to either a low-sphere or high-sphere arm based on refraction measurements in the baseline assessment. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Visual Acuity
What is being tested?
JJVC Marketed Contact Lens
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
1 siteUnited Kingdom
Study dates
10 May 2021to 28 Jun 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 40 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 35 (inclusive) years of age at the time of screening.
  • They agree not to participate in other clinical research while enrolled on this study.
  • They have worn the same brand of soft contact lenses at least eight hours per day for at least two days per week over the previous three months.
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  • They own a wearable pair of spectacles if needed for distance vision correction (by self-report).
  • They typically use digital devices for a minimum of 4 hours per day, 5 days per week.
  • In a pre-study screening assessment, they must have a CVS-Q score of 4 or less (asymptomatic group) or 6 or greater (symptomatic group).
  • They can attain a best-corrected logMAR distance visual acuity of at least 0.20 in each eye.
  • They have spherical contact lens prescription in the range +1.00 to -6.00 DS (based on the calculated ocular refraction).
  • They have up to maximum of 0.75 DC of refractive astigmatism (based on the calculated ocular refraction).

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 (e.g., Sjögren's Syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study.
  • They have an ocular disorder which would normally contraindicate contact lens wear.
  • They have had cataract surgery.
  • They have had corneal refractive surgery.
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  • They are regularly (once per day or more) using oral or inhaled steroids or anti-inflammatory medications.
  • They are using any topical medications such as eye drops or ointments.
  • Any known hypersensitivity or allergic reaction to sodium fluorescein.
  • Use of systemic medications (e.g., chronic steroid use) that are known to interfere with contact lens wear. See section 9.1 for additional details regarding excluded systemic medications.
  • Participation in any contact lens or lens care product clinical trial within 2 weeks prior to study enrollment.
  • Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
  • They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
  • They have any existing binocular vision anomalies such as strabismus or have been prescribed prisms in their spectacles based on self-report, or in the opinion of the investigator exhibit signs of suppression during binocular vision testing.
  • Any Efron Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) which in the investigator's opinion would contraindicate contact lens wear.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • The University of Manchester

    Manchester, M13 9PL

Other trials in United Kingdom

About this study

This is a two-arm, open-label, bilateral dispensing clinical investigation. Eligible subjects will proceed to either a low-sphere or high-sphere arm based on refraction measurements in the baseline assessment.

Conditions
Visual Acuity
Being tested
JJVC Marketed Contact Lens

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JJVC Marketed Contact LensDevice

    Also called Test 1

    Acuvue Oasys® 1-Day

Study groups in NCT04869189
Study groupRoleWhat they receive
High SphereOtherSubjects with a spherical refraction between -1.75 DS and -6.00 DS
Receives: Device: JJVC Marketed Contact Lens
Low SphereOtherSubjects with a spherical refraction between -1.50 DS and +1.00 DS
Receives: Device: JJVC Marketed Contact Lens

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual Analogue Scales (VAS)

    Subjective comfort and visual fatigue will be assessed using 0 to 100 on VAS at the start of the visit and at the end of each visual task.

    Measured: at approximately 2-week follow-up

  2. Tear film surface quality

    Tear film surface quality will be assessed in the left eye (OS) only. The infrared-reflected mires from the tear film will be analyzed using custom image analysis from video recordings. The mean and standard deviation of tear film surface quality metric will be determined across the 5 minutes and at 1-minute increments.

    Measured: at approximately 2-week follow-up

  3. Tear meniscus height

    The lower tear meniscus in the left eye (OS) only will be analyzed using custom image analysis from video recordings. The mean and SD of tear meniscus height (measured vertically in millimeters) will be determined across the 5 minutes and at 1-minute increments.

    Measured: at approximately 2-week follow-up

  4. Blink frequency

    Blink frequency will be analyzed using custom image analysis from video recordings. Three blink rate metrics will be determined:

    1. Total blink rate: blinks per minute (all blinks)
    2. Complete blink rate: complete blinks per minute. A complete blink will be defined as having a closed palpebral aperture of less than one third of the open palpebral aperture.
    3. Incomplete blink rate: incomplete blinks per minute. An incomplete blink will be defined as having a closed palpebral aperture of more than one third of the open palpebral aperture.

    Each blink frequency metric will be determined across the 5 minutes and at 1-minute increments.

    Measured: at approximately 2-week follow-up

  5. Interblink interval

    The distribution of interblink intervals (seconds) over the 5-minute measurement period and at 1-minute increments will be determined in two ways:

    1. Total interblink interval: time in seconds between any blinks
    2. Complete interblink interval: time in seconds between complete blinks

    The number of times the interblink interval exceeds the mean + 1SD tear film break up time (assessed over the extended eye opening periods) will be determined for:

    1. Total interblink interval distribution
    2. Complete interblink interval distribution

    Measured: at approximately 2-week follow-up

  6. Blink completeness

    The mean and SD of the maximally closed palpebral aperture (in mm) will be summarized for total blinks, complete blinks and incomplete blinks across the 5 minutes. For total blinks, the mean and SD of maximally closed palpebral aperture will also be determined at 1-minute increments.

    Measured: at approximately 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.

  1. First posted3 May 2021
  2. Study start10 May 2021
  3. Primary completion28 Jun 2022
  4. Study completion28 Jun 2022

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04869189
Sponsor's protocol ID
CR-6384
Status last verified
Jul 2023
First submitted
28 Apr 2021
Last updated
21 Jul 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

Questions about this trial

What is this clinical trial studying?

A study testing JJVC Marketed Contact Lens 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 12 inclusion and 15 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 21 Jul 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?

Visual Analogue Scales (VAS) (time frame: at approximately 2-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?

On the ClinicalTrials.gov record for NCT04869189.

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 21 Jul 2023.

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