Pilot Dispensing Study of Two Marketed Daily Disposable Multifocal Contact Lenses
NCT ID: NCT07076160
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
74 participants
INTERVENTIONAL
2025-07-24
2025-09-20
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
SINGLE
Study Groups
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Test/Control/Control
Eligible subjects will be randomized into the Test/Control/Control sequence.
INFUSE® One Day Multifocal
Test Lens
ACUVUE® OASYS MAX 1-Day Multifocal Contact Lens
Control Lens
Control/Test/Test
Eligible subjects will be randomized into the Control/Test/Test sequence.
INFUSE® One Day Multifocal
Test Lens
ACUVUE® OASYS MAX 1-Day Multifocal Contact Lens
Control Lens
Interventions
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INFUSE® One Day Multifocal
Test Lens
ACUVUE® OASYS MAX 1-Day Multifocal Contact Lens
Control Lens
Eligibility Criteria
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Exclusion Criteria
2. Have any active or ongoing ocular or systemic allergies that may interfere with contact lens wear.
3. Have been diagnosed with diabetes.
4. Have any active or ongoing systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This includes, but not be limited to, hyperthyroidism, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g. hepatitis, tuberculosis).
5. Have any previous, or planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, lid procedures, dacryocystorhinostomy, peripheral iridotomy/iridectomy, cataract surgery, retinal surgery, etc.).
6. Have a history of amblyopia, strabismus or binocular vision abnormality.
7. Use of any of the following medications within 1 week prior to enrollment: oral retinoid, oral tetracyclines, anticholinergics, oral phenothiazines, oral/inhaled corticosteroids. See section 9.1 for further examples.
8. Be currently using any ocular medications with the exception of rewetting drops.
9. Have a history of herpetic keratitis.
10. Have a history of irregular cornea.
11. Have a history of pathological dry eye.
12. Have participated in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.
13. Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an employee (including partner, child, parent, grandparent, grandchild, sibling of the employee or their spouse) of the clinical site.
14. Have any known hypersensitivity or allergic reaction to non-preserved rewetting drop solutions or sodium fluorescein.
15. 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).
16. Have any current ocular infection or inflammation.
40 Years
70 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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Dr. James Weber & Associates, PA - City Square Blvd
Jacksonville, Florida, United States
VRC
Jacksonville, Florida, United States
Pearson Research Center, PA
Longwood, Florida, United States
Maitland Vision Center - North Orlando Ave
Maitland, Florida, United States
Sacco Eye Group
Vestal, New York, United States
Luxe Vision and Optical
Powell, Ohio, United States
Dr. David W. Ferris & Associates
Warwick, Rhode Island, United States
Countries
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Other Identifiers
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CR-6612
Identifier Type: -
Identifier Source: org_study_id