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

NCT06749496 | Completed FDA Device

• 1 other identifier: CR-6594
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 12

Brief 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.

Conditions

Astigmatism

Outcome Measures

Primary Outcomes (1)

• Patient Reported Outcome: Comfort

  Comfort, with respect to contact lens wear, will be assessed using the individual questionnaire item: 'I could wear these contact lenses comfortably for as long as I wanted to'. This item will utilize an agreement scale of, 1: Strongly Disagree, 2: Disagree, 3: Neither Agree nor Disagree, 4: Agree and 5: Strongly Agree.

  Up to 1-week follow-up

Secondary Outcomes (2)

• Overall Opinion

  Up to 1-week follow-up

• Comfort at the End of the Day

  Up to 1-week follow-up

Study Arms (2)

Test/Control

EXPERIMENTAL

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; Device: Control Lens

Control/Test

EXPERIMENTAL

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; Device: Control Lens

Interventions

Test Lens DEVICE

ACUVUE® OASYS MAX 1-Day for ASTIGMATISM (AOM1DfA).

Control/Test; Test/Control

Control Lens DEVICE

Alcon DAILIES TOTAL1® for Astigmatism Contact Lenses (DT1fA).

Control/Test; Test/Control

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (12)

Stam & Associates Eye Care

Jacksonville, Florida, 32256, United States

Location

Omega Vision Center

Longwood, Florida, 32779, United States

Location

Maitland Vision Center - North Orlando Ave

Maitland, Florida, 32751, United States

Location

Kannarr Eye Care - 101 North Broadway

Pittsburg, Kansas, 66762, United States

Location

Birmingham Vision Care

Bloomfield Hills, Michigan, 48301, United States

Location

Complete Eye Care of Medina

Medina, Minnesota, 55340, United States

Location

Sacco Eye Group

Vestal, New York, 13850, United States

Location

Procare Vision Centers

Granville, Ohio, 43023, United States

Location

Professional Vision Care Inc. - Westerville

Westerville, Ohio, 43081, United States

Location

Optometry Group, PLLC

Memphis, Tennessee, 38111, United States

Location

Tyler Eye Associates

Tyler, Texas, 75703, United States

Location

Botetourt Eyecare, LLC

Salem, Virginia, 24153, United States

Location

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Johnson & Johnson Vision Care, Inc. Clinical Trial

  Johnson & Johnson Vision Care, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: December 27, 2024
• Study Start: January 7, 2025
• Primary Completion: March 20, 2025
• Study Completion: March 20, 2025
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (12)