Purpose

This is a prospective, multi-site, dispensing, randomized, controlled, double-masked, bilateral wear, 2x2 crossover study to evaluate the safety and effectiveness of the test lens.

Condition

Eligibility

Eligible Ages
Between 18 Years and 39 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Criteria

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 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 last 30 days.

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

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

1. Sphere powers (DS) -1.50 through -4.00 (inclusive) in 0.25 steps

2. Cylinder powers (DC) -0.75 and -1.25

3. Axes (°) 170, 180, 10, 80, 90, 100

7. Have best corrected monocular distance visual acuity of 20/30 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. Be currently using any ocular medications or have an 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, Photorefractive Keratectomy [PRK], Laser-Assisted in Situ
Keratomileusis [LASIK], iridotomy, retinal laser photocoagulation, etc.).

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Test/Control
Eligible subjects will be randomized to the Test/Control sequence, to wear the Test Lens followed by the Control Lens bilaterally for approximately 1-week each in a daily disposable modality with a washout period of approximately 1-week between wear periods.
  • Device: Investigational daily disposable, soft, toric lenses manufactured on 4th Generation Technology (4GT) lines with extended mini-stack hydration using propylene glycol (PG) as the hydration solvent.
    Test Lens
  • Device: ACUVUE® Oasys 1-Day for Astigmatism (AO1DfA) soft contact lenses manufactured on 3rd Generation Technology (3GT) legacy lines using isopropyl alcohol (IPA) as the hydration solvent.
    Control Lens
Experimental
Control/Test
Eligible subjects will be randomized to the Control/Test sequence, to wear the Control Lens followed by the Test Lens bilaterally for approximately 1-week each in a daily disposable modality with a washout period of approximately 1-week between wear periods.
  • Device: Investigational daily disposable, soft, toric lenses manufactured on 4th Generation Technology (4GT) lines with extended mini-stack hydration using propylene glycol (PG) as the hydration solvent.
    Test Lens
  • Device: ACUVUE® Oasys 1-Day for Astigmatism (AO1DfA) soft contact lenses manufactured on 3rd Generation Technology (3GT) legacy lines using isopropyl alcohol (IPA) as the hydration solvent.
    Control Lens

Recruiting Locations

James R. Dugue, Optometrist
Mission Viejo, California 92691

Scripps Poway Eyecare & Optometry
San Diego, California 92131

Stam & Associates Eye Care
Jacksonville, Florida 32256

Omega Vision Center
Longwood, Florida 32779

Maitland Vision Centers - North Orlando Ave
Maitland, Florida 32751

Mid-State Eye
Clinton, Illinois 61727

Franklin Park Eye Center, P.C.
Franklin Park, Illinois 60131

Kannarr Eye Care - 101 North Broadway
Pittsburg, Kansas 66762

Complete Eye Care of Medina
Medina, Minnesota 55340

Advanced Eyecare - Raytown, MO
Raytown, Missouri 64133

The Koetting Associates
Saint Louis, Missouri 63144

ABQ Eye Care
Albuquerque, New Mexico 87109

Spectrum Eye Care
Jamestown, New York 14750

Sacco Eye Group
Vestal, New York 13850

ProCare Vision Centers
Granville, Ohio 43023

Professional Vision Care Inc. - Westerville
Westerville, Ohio 43081

Optometry Group, PLLC
Memphis, Tennessee 38111

Total Eye Care
Memphis, Tennessee 38119

Tyler Eye Associates
Tyler, Texas 75703

Clarke EyeCare Center
Wichita Falls, Texas 76308

More Details

NCT ID
NCT06967129
Status
Recruiting
Sponsor
Johnson & Johnson Vision Care, Inc.

Study Contact

Study Contact
1-800-843-2020
njoshi30@its.jnj.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.