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Visual AcuityNCT06778057

Clinical Performance of Three Daily Disposable Silicone Hydrogel Contact Lenses

A study testing Test Lens 1, Test Lens 2 and Test Lens 3 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 subject-masked, randomized, prospective, bilateral, 3x3 crossover dispensing clinical investigation to assess the clinical performance of a new lens type comparison. 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?
Test Lens 1, Test Lens 2 and Test Lens 3
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteUnited Kingdom
Study dates
29 Dec 2024to 16 Oct 2025
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

Potential subjects must satisfy all of the following criteria to be enrolled in the study:

  1. Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form
  2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
  3. Be between 18 and 40 (inclusive) years of age at the time of screening.
  4. By self-report, they typically use digital devices for a minimum of 4 hours per day, 5 days per week.
  5. In a pre-study screening assessment, they must have a CVS-Q score of 6 or greater.
  6. Agree not to participate in other clinical research while enrolled on this study.
  7. Own a wearable pair of spectacles, if needed, for distance vision correction (by self-report).
  8. By self-report, habitually wear silicone hydrogel soft contact lenses in both eyes in a daily reusable or daily disposable wear modality (i.e. not extended wear modality). Habitual wear is defined as a minimum of 8 hours of wear per day, for at least 4 days per week over the past 4 weeks.
  9. Attain a best-corrected logMAR distance visual acuity of at least 0.20 in each eye.
  10. Have spherical contact lens prescription in the range -1.00 to -6.00 DS (based on the calculated ocular refraction) in each eye.
  11. Have up to a maximum of 1.00 DC of refractive astigmatism (based on the calculated ocular refraction) in each eye.

Potential subjects who meet any of the following criteria will be excluded from participating in the study:

  1. Be currently pregnant or lactating.
  2. By self-report, have 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, which in the opinion of the investigator is likely to interfere with contact lens wear and/or participation in the study or may pose a risk to study personnel.
  3. Have an ocular disorder which would normally contraindicate contact lens wear.
  4. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months.
  5. Be currently wearing monovision or multifocal contact lenses.
  6. Be currently wearing or have had worn Acuvue® Oasys 1-Day, Dailies® Total1, or Clariti 1-Day lenses during the last 3 months.
  7. Have had cataract surgery.
  8. Have had corneal refractive surgery.
  9. Be using any topical medications such as eye drops or ointments.
  10. Have a known hypersensitivity or allergic reaction to sodium fluorescein.
  11. 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.
  12. Participation in any contact lens or lens care product clinical trial within 2 weeks prior to study enrolment
  13. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
  14. Have clinically significant (grade 3 or higher on the Efron grading scale) slit lamp findings (e.g., corneal edema, neovascularization or staining, tarsal abnormalities or bulbar injection) or other corneal or ocular disease or abnormalities that in the opinion of the investigator would contraindicate contact lens wear or may otherwise compromise study endpoints (including entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, moderate or above corneal distortion, herpetic keratitis).
  15. Have fluctuations in vision due to clinically significant dry eye or other ocular conditions.
  16. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • The University of Manchester, Department of Optometry & Neuroscience

    Manchester, M13 9PL

Other trials in United Kingdom

About this study

This is a subject-masked, randomized, prospective, bilateral, 3x3 crossover dispensing clinical investigation to assess the clinical performance of a new lens type comparison.

Conditions
Visual Acuity
Being tested
Test Lens 1, Test Lens 2, Test Lens 3

What participants receive

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

  • Test Lens 1Device

    Acuvue® Oasys MAX 1-Day daily disposable contact lenses

  • Test Lens 2Device

    Dailies Total 1 daily disposable contact lenses

  • Test Lens 3Device

    Clariti 1-Day daily disposable contact lenses

Study groups in NCT06778057
Study groupRoleWhat they receive
Test Lens 1/Test Lens 2/Test Lens 3ExperimentalEligible subjects will be randomized into the Test Lens 1/Test Lens 2/Test Lens 3 sequence, to wear each lens for up to 10 hours each.
Receives: Device: Test Lens 1; Device: Test Lens 2; Device: Test Lens 3
Test Lens 1/Test Lens 3/Test Lens 2ExperimentalEligible subjects will be randomized into the Test Lens 1/Test Lens 3/Test Lens 2 sequence, to wear each lens for up to 10 hours each.
Receives: Device: Test Lens 1; Device: Test Lens 2; Device: Test Lens 3
Test Lens 2/Test Lens 1/Test Lens 3ExperimentalEligible subjects will be randomized into the Test Lens 2/Test Lens 1/Test Lens 3 sequence, to wear each lens for up to 10 hours each.
Receives: Device: Test Lens 1; Device: Test Lens 2; Device: Test Lens 3
Test Lens 2/Test Lens 3/Test Lens 1ExperimentalEligible subjects will be randomized into the Test Lens 2/Test Lens 3/Test Lens 1 sequence, to wear each lens for up to 10 hours each.
Receives: Device: Test Lens 1; Device: Test Lens 2; Device: Test Lens 3
Test Lens 3/Test Lens 1/Test Lens 2ExperimentalEligible subjects will be randomized into the Test Lens 3/Test Lens 1/Test Lens 2 sequence, to wear each lens for up to 10 hours each.
Receives: Device: Test Lens 1; Device: Test Lens 2; Device: Test Lens 3
Test Lens 3/Test Lens 2/Test Lens 1ExperimentalEligible subjects will be randomized into the Test Lens 3/Test Lens 2/Test Lens 1 sequence, to wear each lens for up to 10 hours each.
Receives: Device: Test Lens 1; Device: Test Lens 2; Device: Test Lens 3

What is being measured

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

  1. Lens Fit Acceptance

    Lens Fit Acceptance: Lens fit acceptance will be assessed at dispensing and follow-up visits for each subject eye.

    An unacceptable fit is deemed by one or more of the following criteria:

    • limbal exposure at primary gaze or with extreme eye movement.
    • edge lift.
    • excessive movement with blink in primary gaze.
    • insufficient movement with blink in upgaze.
    • insufficient movement in push-up test.

    Measured: Follow-up assessments will be made approximately 8-10 hours after lens dispensing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2025
  2. Study start29 Dec 2024
  3. Primary completion16 Oct 2025
  4. Study completion16 Oct 2025

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
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06778057
Sponsor's protocol ID
CR-6595
Status last verified
Jun 2026
First submitted
27 Dec 2024
Last updated
5 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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 Test Lens 1, Test Lens 2 and Test Lens 3 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?

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 5 Jun 2026. 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?

Lens Fit Acceptance (time frame: Follow-up assessments will be made approximately 8-10 hours after lens dispensing). 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 5 Jun 2026.

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