ClinicalTrials.gg
Active, not recruitingNCT07819305Updated Nov 3, 2026

Evaluation of Approved Contact Lenses (CR-6657)

An interventional study of Test (Senofilcon A) and Control (Serafilcon A) in Visual Acuity, sponsored by Johnson & Johnson Vision Care, Inc.. Active, not recruiting at 8 sites in United States. Open to participants aged 18 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Johnson & Johnson Vision Care, Inc. (part of Johnson & Johnson) · Not applicable, Interventional, and Treatment

Updated Nov 3, 2026Now Active, not recruitingNow Recruiting+2 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
145
Allocation
Randomized
Ages
18 Years to 39 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Visual Acuity
03

In context

Lead sponsor

Johnson & Johnson Vision Care, Inc. is the lead sponsor of 221 studies on the registry; 1 is open to participants now.

Of its 111 completed or terminated interventional studies of FDA-regulated products, 103 (93%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 39 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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

  1. Read, understand, and sign the STATEMENT OF 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 39 (inclusive) years of age at the time of screening.
  4. By self-report, habitually wear reusable spherical (not toric or multifocal) silicone hydrogel contact lenses in both eyes in a daily wear modality (i.e., not extended wear). Habitual wear is defined as a self-reported minimum of 6 hours of wear per day and 5 days per week during the past 30 days.
  5. Have a habitual contact lens prescription that is current within the prior 12 months, and they must have worn that prescription for at least 2 weeks prior to entering the study.
  6. Possess a wearable pair of spectacles that provide correction for distance vision.

    Inclusion criteria at baseline evaluation

  7. The vertex corrected subjective best sphere distance refraction must be between -1.00 D and -6.00 D (inclusive) in each eye.
  8. 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.
  9. 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:

  1. Be currently pregnant or lactating.
  2. Be diabetic.
  3. Have any current ocular infection of any type.
  4. 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.
  5. 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.
  6. 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 disease (e.g., [HIV]), 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.
  7. Have habitually worn rigid gas permeable (RGP) contact lenses, orthokeratology lenses, or hybrid lenses (e.g., SynergEyes, SoftPerm) within the past 6 months.
  8. Be currently wearing monovision, multifocal, or toric soft contact lenses.
  9. Be currently wearing lenses in an extended wear modality.
  10. Have a self-reported history of allergy, , 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.
  11. Have participated in a contact lens or lens care product trial within 14 days prior to study enrollment.
  12. 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.
  13. Have (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).
  14. Have strabismus (constant or intermittent) or amblyopia.
  15. Have fluctuations in vision due to clinically significant dry eye or other ocular conditions.
  16. 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.).
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
145 participants (actual)

Study arms

  • Experimental
    Test/Control

    Eligible 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.

    Device: Test (Senofilcon A) · Device: Control (Serafilcon A)

  • Experimental
    Control/Test

    Eligible 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.

    Device: Test (Senofilcon A) · Device: Control (Serafilcon A)

Interventions

  • DeviceTest (Senofilcon A)

    Test Lens

  • DeviceControl (Serafilcon A)

    Precision7®

06

What researchers measure

Primary outcomes

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

    Time frame: At 2-week follow-up

07

Study locations

8 sites
  • VRC
    Jacksonville, Florida 32256, United States
  • Franklin Park Eye Center, P.C.
    Franklin Park, Illinois 60131, United States
  • Eyecare Center of Camden
    Camden, New York 13316, United States
  • ProCare Vision Centers
    Granville, Ohio 43023, United States
  • New Bremen EyeCare
    New Bremen, Ohio 45869, United States
  • Total Eye Care
    Memphis, Tennessee 38119, United States
  • Paradigm Research Center, LLC
    Houston, Texas 77030, United States
  • Botetourt Eyecare, LLC
    Salem, Virginia 24153, United States
08

References and documents

Individual participant data

Plan to share: 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

Data sharing details ↗ · yoda.yale.edu

No publications or documents are linked to this record.

09

Updates

2 registry updates since Sep 25, 2026
Status
Not yet recruiting→Recruiting→Active, not recruiting
changed Sep 29, 2026 · changed Nov 3, 2026
Sites
8 sites changed recruiting status (4 now recruiting, 3 now not yet recruiting, …)
Show 8 sites
  • VRC · Jacksonville, United Statesno status→Active, not recruiting
  • Franklin Park Eye Center, P.C. · Franklin Park, United Statesno status→Recruiting
  • Eyecare Center of Camden · Camden, United Statesno status→Not yet recruiting
  • ProCare Vision Centers · Granville, United Statesno status→Recruiting
  • New Bremen EyeCare · New Bremen, United Statesno status→Not yet recruiting
  • Total Eye Care · Memphis, United Statesno status→Recruiting
  • Paradigm Research Center, LLC · Houston, United Statesno status→Not yet recruiting
  • Botetourt Eyecare, LLC · Salem, United Statesno status→Recruiting
Sep 29, 2026
Enrollment
150 (estimated)→145 (actual)
Nov 3, 2026
Show all 2 updates
  1. Nov 3, 2026
    Recruiting→Active, not recruiting
    Enrollment 150 (estimated)→145 (actual)
    + 3 other changes: verification date, contact details and site details
  2. Sep 29, 2026
    Not yet recruiting→Recruiting
    8 sites changed recruiting status (4 now recruiting, 3 now not yet recruiting, …)
    Show 8 sites
    • VRC · Jacksonville, United Statesno status→Active, not recruiting
    • Franklin Park Eye Center, P.C. · Franklin Park, United Statesno status→Recruiting
    • Eyecare Center of Camden · Camden, United Statesno status→Not yet recruiting
    • ProCare Vision Centers · Granville, United Statesno status→Recruiting
    • New Bremen EyeCare · New Bremen, United Statesno status→Not yet recruiting
    • Total Eye Care · Memphis, United Statesno status→Recruiting
    • Paradigm Research Center, LLC · Houston, United Statesno status→Not yet recruiting
    • Botetourt Eyecare, LLC · Salem, United Statesno status→Recruiting
    + 1 other change: date precision

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07819305
Responsible party
Sponsor
First posted
Sep 14, 2026
Start date
Sep 10, 2026
Primary completion
Dec 3, 2026 (estimated)
Completion
Dec 3, 2026 (estimated)
Last update
Nov 3, 2026

Study contacts

Johnson & Johnson Vision Care, Inc. Clinical Trial
study director · Johnson & Johnson Vision Care, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion