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Visual AcuityNCT07819305

Evaluation of Approved Contact Lenses (CR-6657)

A study testing Test (Senofilcon A) in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 8 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a prospective, multi-site, bilateral, 2-week dispensing, randomized, controlled, single-masked (subjects), 2x2 crossover study to evaluate visual acuity. 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?
Test (Senofilcon A)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
145 participants
Where
8 sitesUnited States
Study dates
10 Sep 2026to 3 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • The vertex corrected subjective best sphere distance refraction must be between -1.00 D and -6.00 D (inclusive) in each eye.
  • The magnitude of the cylindrical component of the subject's vertex corrected distance refraction must be less than or equal to 1.00 D (inclusive) in each eye with any degree of axis.
  • The best corrected, monocular, distance visual acuity must be 20/25 or better in each eye.
  • Potential subjects who meet any of the following criteria will be excluded from participating in the study:
  • Be currently pregnant or lactating.
  • Be diabetic.
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  • Have any current ocular infection of any type.
  • Be currently using any ocular medications. The use of topical ophthalmic allergy medications may be acceptable provided the medication regimen has remained stable for at least 14 days prior to enrollment and is expected to remain unchanged throughout study participation. All ophthalmic medications must be administered according to the approved product labeling, including any instructions regarding contact lens removal and reinsertion. Any changes in medication type, dose, frequency, duration, or administration instructions during the study will be documented and may result in a protocol deviation or study discontinuation.
  • Routinely require or use artificial tears, lubricant eye drops, or contact lens rewetting drops for successful contact lens wear. Subjects with occasional, non-routine use may be enrolled provided they self-report discontinuation prior to enrollment and agree to refrain from their use during the study. Use of artificial tears, lubricant eye drops, or contact lens rewetting drops during a study lens wear period is not permitted. Any such use during the study will be documented and may result in a protocol deviation or study discontinuation.
  • By self-report, have any ocular or systemic disease, allergies, infection, or use of medication that the investigator believes 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 habitually worn rigid gas permeable (RGP) contact lenses, orthokeratology lenses, or hybrid lenses (e.g., SynergEyes, SoftPerm) within the past 6 months.
  • Be currently wearing monovision, multifocal, or toric soft contact lenses.
  • Be currently wearing lenses in an extended wear modality.
  • Have a self-reported history of allergy, hypersensitivity, or intolerance to any study product or ancillary supply that, in the Investigator's judgment, could interfere with study participation or evaluation of study endpoints.
  • Have participated in a contact lens or lens care product trial within 14 days prior to study enrollment.
  • 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 clinically significant (grade 3 or higher on the FDA 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 the investigator believes might 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).
  • Have strabismus (constant or intermittent) or amblyopia.
  • Have fluctuations in vision due to clinically significant dry eye or other ocular conditions.
  • Have had or have planned (within the study period) any ocular or intraocular surgery that may impact contact lens wear or study participation (e.g., radial keratotomy, PRK, LASIK, iridotomy, retinal laser photocoagulation, etc.).

Who cannot join

None listed.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Eyecare Center of Camden

    Camden, New York, 13316

  • Franklin Park Eye Center, P.C.

    Franklin Park, Illinois, 60131

  • ProCare Vision Centers

    Granville, Ohio, 43023

  • Paradigm Research Center, LLC

    Houston, Texas, 77030

  • VRC

    Jacksonville, Florida, 32256

  • Total Eye Care

    Memphis, Tennessee, 38119

  • New Bremen EyeCare

    New Bremen, Ohio, 45869

  • Botetourt Eyecare, LLC

    Salem, Virginia, 24153

Other trials in United States

About this study

Official title: Evaluation of Approved Contact Lenses

This is a prospective, multi-site, bilateral, 2-week dispensing, randomized, controlled, single-masked (subjects), 2x2 crossover study to evaluate visual acuity.

Conditions
Visual Acuity
Being tested
Test (Senofilcon A), Control (Serafilcon A)

What participants receive

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

  • Test (Senofilcon A)Device

    Test Lens

  • Control (Serafilcon A)Device

    Precision7®

Study groups in NCT07819305
Study groupRoleWhat they receive
Test/ControlExperimentalEligible subjects will be randomized to the Test/Control sequence, to wear the Test Lens for approximately 2 weeks, undergo a 2-week washout period, and then wear the Control lens for approximately 2 weeks.
Receives: Device: Test (Senofilcon A); Device: Control (Serafilcon A)
Control/TestExperimentalEligible subjects will be randomized to the Control/Test sequence, to wear the Control Lens for approximately 2 weeks, undergo a 2-week washout period, and then wear the Test lens for approximately 2 weeks.
Receives: Device: Test (Senofilcon A); Device: Control (Serafilcon A)

What is being measured

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

  1. Binocular High Luminance, Low Contrast (HLLC) Distance (4 meters) Visual Acuity (logMAR) at 2-week Follow-up

    Measured: At 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 posted14 Sep 2026
  2. Study start10 Sep 2026
  3. Primary completion3 Dec 2026 (estimated)
  4. Study completion3 Dec 2026 (estimated)

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
145 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07819305
Sponsor's protocol ID
CR-6657
Status last verified
Nov 2026
First submitted
8 Sep 2026
Last updated
3 Nov 2026
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 Test (Senofilcon A) in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 8 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 20 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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?

This study is still under way. Results are not available in the source record yet.

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?

Binocular High Luminance, Low Contrast (HLLC) Distance (4 meters) Visual Acuity (logMAR) at 2-week Follow-up (time frame: At 2-week follow-up). 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 NCT07819305.

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 3 Nov 2026.

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