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

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.

Study Overview

• Status: Completed
• Conditions: Astigmatism
• Intervention / Treatment: Device: Test Lens; Device: Control Lens

• Study Type: Interventional
• Enrollment (Actual): 134
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32256
      • Stam & Associates Eye Care
    • Longwood, Florida, United States, 32779
      • Omega Vision Center
    • Maitland, Florida, United States, 32751
      • Maitland Vision Center - North Orlando Ave
  • Kansas
    • Pittsburg, Kansas, United States, 66762
      • Kannarr Eye Care - 101 North Broadway
  • Michigan
    • Bloomfield Hills, Michigan, United States, 48301
      • Birmingham Vision Care
  • Minnesota
    • Medina, Minnesota, United States, 55340
      • Complete Eye Care of Medina
  • New York
    • Vestal, New York, United States, 13850
      • Sacco Eye Group
  • Ohio
    • Granville, Ohio, United States, 43023
      • Procare Vision Centers
    • Westerville, Ohio, United States, 43081
      • Professional Vision Care Inc. - Westerville
  • Tennessee
    • Memphis, Tennessee, United States, 38111
      • Optometry Group, PLLC
  • Texas
    • Tyler, Texas, United States, 75703
      • Tyler Eye Associates
  • Virginia
    • Salem, Virginia, United States, 24153
      • Botetourt Eyecare, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

7. 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test/Control; Eligible subjects will be randomized into the Test/Control sequence, to wear each study lens (Test lens and Control lens) in a daily disposable modality for approximately one week with a washout period of one week between study lens wear periods.	Device: Test Lens; ACUVUE® OASYS MAX 1-Day for ASTIGMATISM (AOM1DfA).; Device: Control Lens; Alcon DAILIES TOTAL1® for Astigmatism Contact Lenses (DT1fA).
Experimental: Control/Test; Eligible subjects will be randomized into the Control/Test sequence, to wear each study lens (Control lens and Test lens) in a daily disposable modality for approximately one week with a washout period of one week between study lens wear periods.	Device: Test Lens; ACUVUE® OASYS MAX 1-Day for ASTIGMATISM (AOM1DfA).; Device: Control Lens; Alcon DAILIES TOTAL1® for Astigmatism Contact Lenses (DT1fA).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long Lasting Comfort	Long lasting comfort, with respect to contact lens wear, was assessed using the individual questionnaire item: 'I could wear these contact lenses comfortably for as long as I wanted to'. This item utilized an agreement scale of, 1: Strongly Disagree, 2: Disagree, 3: Neither Agree nor Disagree, 4: Agree and 5: Strongly Agree. Long lasting comfort was assessed after 1-week of lens wear. Subjects' responses to this questionnaire item were dichotomized as Y=1 if a subject responds Strongly Agree or Agree and Y=0, otherwise. The difference in percentage of subjects that agree or strongly agree (Y=1) to the long lasting comfort was analyzed. The percentage of subjects with Y=1 in the Test lens was compared to the percentage of subjects with Y=1 in the control lens.	1-week Follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Opinion	Overall opinion, with respect to the study contact lenses, was evaluated using the individual questionnaire item 'Considering your experience with the study contact lenses, which statement best describes your overall opinion of these contact lenses?'. This item utilized an excellence scale of, 1: Poor, 2: Fair, 3: Good, 4: Very Good and 5: Excellent. Overall opinion was assessed after 1-week of lens wear. Subjects' responses to this questionnaire item were dichotomized as Y=1 if a subject responds Excellent or Very good and Y=0, otherwise. The difference in percentage of subjects that agree or strongly agree (Y=1) to the long lasting comfort was analyzed. The percentage of subjects with Y=1 in the Test lens was compared to the percentage of subjects with Y=1 in the control lens.	1-Week Follow-up
Comfort at the End of the Day	Comfort at the end of the day, with respect to contact lens wear, was assessed using the individual questionnaire 'These lenses were very comfortable at the end of the day'. This item utilized an agreement scale of, 1: Strongly Disagree, 2: Disagree, 3: Neither Agree nor Disagree, 4: Agree and 5: Strongly Agree. Comfort at the end of the day was assessed after 1-week of lens wear. Subjects' responses to this questionnaire item were dichotomized as Y=1 if a subject responds Strongly Agree or Agree and Y=0, otherwise. The difference in percentage of subjects that agree or strongly agree (Y=1) to the long lasting comfort was analyzed. The percentage of subjects with Y=1 in the Test lens was compared to the percentage of subjects with Y=1 in the control lens.	1-Week Follow-up

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.
• Investigators: Study Director: Johnson & Johnson Vision Care, Inc. Clinical Trial, Johnson & Johnson Vision Care, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2025
• Primary Completion (Actual): March 20, 2025
• Study Completion (Actual): March 20, 2025

Study Registration Dates

• First Submitted: December 23, 2024
• First Submitted That Met QC Criteria: December 23, 2024
• First Posted (Actual): December 27, 2024

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: CR-6594

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes