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
53 participants
INTERVENTIONAL
2025-03-30
2025-05-05
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 Lens/Control Lens
Eligible subjects will be randomized into the Test Lens/Control Lens sequence, to wear the Test Lens followed by the Control Lens in a bilateral fashion, with a washout period of 5-minutes between wear periods.
etafilcon A with PVP with cosmetic pattern contact lens
Test Lens
1-DAY ACUVUE® DEFINE® with LACREON®, FRESH Honey
Control Lens
Control Lens/Test Lens
Eligible subjects will be randomized into the Control Lens/Test Lens sequence, to wear the Control Lens followed by the Test Lens in a bilateral fashion, with a washout period of 5-minutes between wear periods.
etafilcon A with PVP with cosmetic pattern contact lens
Test Lens
1-DAY ACUVUE® DEFINE® with LACREON®, FRESH Honey
Control Lens
Interventions
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etafilcon A with PVP with cosmetic pattern contact lens
Test Lens
1-DAY ACUVUE® DEFINE® with LACREON®, FRESH Honey
Control Lens
Eligibility Criteria
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Exclusion Criteria
2. Have any systemic disease (eg, Sjögren's Syndrome), allergies, infectious disease (eg, hepatitis, tuberculosis), contagious immunosuppressive diseases (eg, HIV), autoimmune disease (eg rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study (at the investigator's discretion).
3. Use of systemic medications (eg, chronic steroid use) that are known to interfere with contact lens wear (at the investigator's discretion).
4. Have any previous, or planned (during the study), ocular surgery (eg, radial keratotomy, PRK, LASIK, etc.).
5. Have any previous history or signs of a contact lens-related corneal inflammatory event (eg, past peripheral ulcer or round peripheral scar), or any other ocular abnormality that would contraindicate contact lens wear (at the investigator's discretion).
6. Have participated in any contact lens or lens care product clinical trial within seven (7) days prior to study enrollment.
7. 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.
8. Have any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion (at the investigator's discretion).
9. Have any clinically significant (Grade 3 or 4 on FDA scale) tarsal abnormalities, bulbar injection, corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
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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Maitland Vision Center - North Orlando Ave
Maitland, Florida, United States
Countries
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Other Identifiers
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CR-6571
Identifier Type: -
Identifier Source: org_study_id