Evaluation of Delefilcon A and Senofilcon A Daily Disposable Toric Soft Contact Lenses Over One Week of Wear

Last updated: April 2, 2025
Sponsor: Johnson & Johnson Vision Care, Inc.
Overall Status: Completed

Phase

N/A

Condition

Astigmatism

Treatment

Test Lens

Control Lens

Clinical Study ID

NCT06749496
CR-6594
  • Ages 18-39
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This is a prospective, multi-site, 4-visit, bilateral, dispensing, randomized, controlled, double-masked, 2x2 crossover study to evaluate subjective comfort, overall opinion and end of day comfort following wear of two different contact lenses.

Eligibility Criteria

Inclusion

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

The subject must:

  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 39 (inclusive) years of age at the time of screening.

  4. By self-report, habitually wear 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 6 hours of wear per day, for a minimum of 2 days per week during the past four weeks.

  5. Possess a wearable pair of spectacles that provide correction for distance vision.

  6. In both eyes, have refractive error suitable for correction with the range of toric contact lens powers available in this study:

6.1 Sphere powers (DS) -1.50 through -4.00 (inclusive) in 0.25 steps 6.2 Cylinder powers (DC) -0.75 and -1.25 6.3 Axes (°) 170, 180, 10, 80, 90 and 100

  1. Have best corrected monocular distance visual acuity of 20/25 or better in each eye.

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

The subject must not:

  1. Be currently pregnant or lactating.

  2. Be diabetic.

  3. Be currently using any ocular medications or have any ocular infection of any type.

  4. 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. See section 9.1 for additional details regarding excluded systemic medications.

  5. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g., SynergEyes, SoftPerm) within the past 6 months.

  6. Be currently wearing monovision or multifocal contact lenses.

  7. Be currently wearing lenses in an extended wear modality.

  8. Have a history of strabismus or amblyopia.

  9. 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.

  10. Have participated in a contact lens or lens care product clinical trial within 7 days prior to study enrollment.

  11. 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 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).

  12. Have fluctuations in vision due to clinically significant dry eye or other ocular conditions.

  13. Have had or have planned (within the study period) any ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, iridotomy, retinal laser photocoagulation, etc.).

Study Design

Total Participants: 134
Treatment Group(s): 2
Primary Treatment: Test Lens
Phase:
Study Start date:
January 07, 2025
Estimated Completion Date:
March 20, 2025

Connect with a study center

  • Stam & Associates Eye Care

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Omega Vision Center

    Longwood, Florida 32779
    United States

    Site Not Available

  • Maitland Vision Center - North Orlando Ave

    Maitland, Florida 32751
    United States

    Site Not Available

  • Kannarr Eye Care - 101 North Broadway

    Pittsburg, Kansas 66762
    United States

    Site Not Available

  • Birmingham Vision Care

    Bloomfield Hills, Michigan 48301
    United States

    Site Not Available

  • Complete Eye Care of Medina

    Medina, Minnesota 55340
    United States

    Site Not Available

  • Sacco Eye Group

    Vestal, New York 13850
    United States

    Site Not Available

  • Procare Vision Centers

    Granville, Ohio 43023
    United States

    Site Not Available

  • Professional Vision Care Inc. - Westerville

    Westerville, Ohio 43081
    United States

    Site Not Available

  • Optometry Group, PLLC

    Memphis, Tennessee 38111
    United States

    Site Not Available

  • Tyler Eye Associates

    Tyler, Texas 75703
    United States

    Site Not Available

  • Botetourt Eyecare, LLC

    Salem, Virginia 24153
    United States

    Site Not Available

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