Evaluation of Daily Disposable Toric Soft Lenses Manufactured With an Alternative Hydration Process
NCT ID: NCT06967129
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
281 participants
INTERVENTIONAL
2025-04-25
2025-07-14
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 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.
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
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
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.
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
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
Interventions
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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
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
Eligibility Criteria
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Exclusion Criteria
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.).
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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James R. Dugue, Optometrist
Mission Viejo, California, United States
Scripps Poway Eyecare & Optometry
San Diego, California, United States
Stam & Associates Eye Care
Jacksonville, Florida, United States
Pearson Research Center PA
Longwood, Florida, United States
Maitland Vision Centers - North Orlando Ave
Maitland, Florida, United States
Mid-State Eye
Clinton, Illinois, United States
Franklin Park Eye Center, P.C.
Franklin Park, Illinois, United States
Kannarr Eye Care - 101 North Broadway
Pittsburg, Kansas, United States
Complete Eye Care of Medina
Medina, Minnesota, United States
Advanced Eyecare - Raytown, MO
Raytown, Missouri, United States
The Koetting Associates
St Louis, Missouri, United States
ABQ Eye Care
Albuquerque, New Mexico, United States
Spectrum Eye Care
Jamestown, New York, 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
Total Eye Care
Memphis, Tennessee, United States
Tyler Eye Associates
Tyler, Texas, United States
Clarke EyeCare Center
Wichita Falls, Texas, United States
Countries
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Other Identifiers
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CR-6590
Identifier Type: -
Identifier Source: org_study_id