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
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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COMPLETED
NA
134 participants
INTERVENTIONAL
2025-01-07
2025-03-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
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.
Test Lens
ACUVUE® OASYS MAX 1-Day for ASTIGMATISM (AOM1DfA).
Control Lens
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.
Test Lens
ACUVUE® OASYS MAX 1-Day for ASTIGMATISM (AOM1DfA).
Control Lens
Alcon DAILIES TOTAL1® for Astigmatism Contact Lenses (DT1fA).
Interventions
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Test Lens
ACUVUE® OASYS MAX 1-Day for ASTIGMATISM (AOM1DfA).
Control Lens
Alcon DAILIES TOTAL1® for Astigmatism Contact Lenses (DT1fA).
Eligibility Criteria
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Exclusion Criteria
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.).
18 Years
39 Years
ALL
Yes
Sponsors
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Johnson & Johnson Vision Care, Inc.
INDUSTRY
Responsible Party
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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
Omega Vision Center
Longwood, Florida, United States
Maitland Vision Center - North Orlando Ave
Maitland, Florida, United States
Kannarr Eye Care - 101 North Broadway
Pittsburg, Kansas, United States
Birmingham Vision Care
Bloomfield Hills, Michigan, United States
Complete Eye Care of Medina
Medina, Minnesota, United States
Sacco Eye Group
Vestal, New York, United States
Procare Vision Centers
Granville, Ohio, United States
Professional Vision Care Inc. - Westerville
Westerville, Ohio, United States
Optometry Group, PLLC
Memphis, Tennessee, United States
Tyler Eye Associates
Tyler, Texas, United States
Botetourt Eyecare, LLC
Salem, Virginia, United States
Countries
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Other Identifiers
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CR-6594
Identifier Type: -
Identifier Source: org_study_id