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

NCT ID: NCT06749496

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-07

Study Completion Date

2025-03-20

Brief Summary

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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.

Detailed Description

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Conditions

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Astigmatism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Test Lens

Intervention Type DEVICE

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

Control Lens

Intervention Type DEVICE

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

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.

Group Type EXPERIMENTAL

Test Lens

Intervention Type DEVICE

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

Control Lens

Intervention Type DEVICE

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

Interventions

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Test Lens

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

Intervention Type DEVICE

Control Lens

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

Intervention Type DEVICE

Eligibility Criteria

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Exclusion Criteria

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.).
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Johnson & Johnson Vision Care, Inc. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Vision Care, Inc.

Locations

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Stam & Associates Eye Care

Jacksonville, Florida, United States

Site Status

Omega Vision Center

Longwood, Florida, United States

Site Status

Maitland Vision Center - North Orlando Ave

Maitland, Florida, United States

Site Status

Kannarr Eye Care - 101 North Broadway

Pittsburg, Kansas, United States

Site Status

Birmingham Vision Care

Bloomfield Hills, Michigan, United States

Site Status

Complete Eye Care of Medina

Medina, Minnesota, United States

Site Status

Sacco Eye Group

Vestal, New York, United States

Site Status

Procare Vision Centers

Granville, Ohio, United States

Site Status

Professional Vision Care Inc. - Westerville

Westerville, Ohio, United States

Site Status

Optometry Group, PLLC

Memphis, Tennessee, United States

Site Status

Tyler Eye Associates

Tyler, Texas, United States

Site Status

Botetourt Eyecare, LLC

Salem, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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CR-6594

Identifier Type: -

Identifier Source: org_study_id