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
85 participants
INTERVENTIONAL
2025-09-11
2025-10-27
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
SINGLE
Study Groups
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Control/Test/Test
Eligible subjects will be randomized to the control/test/test sequence, to wear the control lens, the test lens, and the test lens again for 1-week each in a daily disposable modality for at least 5 days per week and 6 hours per day.
B+L Infuse spherical soft contact lenses
Test lens
J&J ACUVUE OASYS 1-Day spherical soft contact lenses
Control lens
Test/Control/Control
Eligible subjects will be randomized to the test/control/control sequence, to wear the test lens, the control lens, and the control lens again for 1-week each in a daily disposable modality for at least 5 days per week and 6 hours per day.
B+L Infuse spherical soft contact lenses
Test lens
J&J ACUVUE OASYS 1-Day spherical soft contact lenses
Control lens
Interventions
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B+L Infuse spherical soft contact lenses
Test lens
J&J ACUVUE OASYS 1-Day spherical soft contact lenses
Control lens
Eligibility Criteria
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Exclusion Criteria
2. Be currently using any ocular medications or have any ocular infection of any type.
3. By self-report, have any ocular or systemic disease, allergies, infection, or use of medication that the investigator believes 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.
4. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months.
5. Be currently wearing monovision or multifocal contact lenses.
6. Be currently wearing lenses in an extended wear modality.
7. Have a known hypersensitivity or allergic reaction to silicone hydrogel soft contact lenses.
8. Have participated in a contact lens or lens care product clinical trial within 14 days prior to study enrollment.
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 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 the investigator believes might 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).
11. Have a history of strabismus or amblyopia.
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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VisualEyes
Roswell, Georgia, United States
New Bremen EyeCare
New Bremen, Ohio, United States
Botetourt Eyecare LLC
Salem, Virginia, United States
New River Vision Care
Oak Hill, West Virginia, United States
Countries
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Other Identifiers
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CR-6617
Identifier Type: -
Identifier Source: org_study_id