Clinical Evaluation of 3 Contact Lens Materials With 3 Solution Types
NCT ID: NCT03466060
Last Updated: 2019-10-02
Study Results
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View full resultsBasic Information
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COMPLETED
NA
130 participants
INTERVENTIONAL
2018-02-07
2018-06-19
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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etafilcon A
Eligible subjects were randomized to the etafilcon A lens in both eyes throughout the entire duration of the study.
Opti-Free : RevitaLens / Clear Care : RevitaLens
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
Opti-Free : RevitaLens / RevitaLens : Clear Care
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
Clear Care : RevitaLens/ Opti-Free : RevitaLens
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
Clear Care : RevitaLens / RevitaLens : Opti-Free
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
RevitaLens : Clear Care/ Opti-Free : RevitaLens
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
RevitaLens : Clear Care / RevitaLens : Opti-Free
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
RevitaLens : Opti-Free / Clear Care : RevitaLens
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
RevitaLens : Opit-Free / RevitaLens : Clear Care
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
senofilcon A
Eligible subjects were randomized to the senofilcon A lens in both eyes throughout the entire duration of the study.
Opti-Free : RevitaLens / Clear Care : RevitaLens
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
Opti-Free : RevitaLens / RevitaLens : Clear Care
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
Clear Care : RevitaLens/ Opti-Free : RevitaLens
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
Clear Care : RevitaLens / RevitaLens : Opti-Free
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
RevitaLens : Clear Care/ Opti-Free : RevitaLens
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
RevitaLens : Clear Care / RevitaLens : Opti-Free
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
RevitaLens : Opti-Free / Clear Care : RevitaLens
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
RevitaLens : Opit-Free / RevitaLens : Clear Care
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
senofilcon C
Eligible subjects were randomized to the senofilcon C lens in both eyes throughout the entire duration of the study.
Opti-Free : RevitaLens / Clear Care : RevitaLens
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
Opti-Free : RevitaLens / RevitaLens : Clear Care
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
Clear Care : RevitaLens/ Opti-Free : RevitaLens
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
Clear Care : RevitaLens / RevitaLens : Opti-Free
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
RevitaLens : Clear Care/ Opti-Free : RevitaLens
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
RevitaLens : Clear Care / RevitaLens : Opti-Free
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
RevitaLens : Opti-Free / Clear Care : RevitaLens
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
RevitaLens : Opit-Free / RevitaLens : Clear Care
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
Interventions
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Opti-Free : RevitaLens / Clear Care : RevitaLens
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
Opti-Free : RevitaLens / RevitaLens : Clear Care
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
Clear Care : RevitaLens/ Opti-Free : RevitaLens
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
Clear Care : RevitaLens / RevitaLens : Opti-Free
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
RevitaLens : Clear Care/ Opti-Free : RevitaLens
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
RevitaLens : Clear Care / RevitaLens : Opti-Free
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
RevitaLens : Opti-Free / Clear Care : RevitaLens
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
RevitaLens : Opit-Free / RevitaLens : Clear Care
Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Subjects must be 18-69 years of age (inclusive).
2. Subjects must be habitual disposable hydrogel or silicone hydrogel (1-day, 2-week, or monthly replacement schedule) soft lens wearer in both eyes. Habitual is defined as at least one (1) month of contact lens wear where the lenses are worn for a minimum of six (6) hours per day and a minimum of five (5) days per week.
3. Subjects must have best corrected visual acuity of 20/25 (Snellen or equivalent) or better in each eye.
4. The subject's refractive sphere (vertexed) must be between -1.00 and -6.00 D in each eye.
5. The subject's refractive cylinder must be less than or equal to -1.00 D in each eye.
6. The subject must have normal eyes (i.e., no ocular medications or infections of any type).
7. Subjects must possess a functional/usable pair of spectacles and bring them to the visit (only if applicable - to the investigators discretion).
8. Subjects must read, understand, and sign the Statement of Informed Consent.
9. Subjects must appear able and willing to adhere to the instructions set forth in this clinical protocol.
Exclusion Criteria
1. Currently pregnant or breast-feeding.
2. Diabetes
3. Any ocular or systemic allergies or disease which may interfere with contact lens wear (at the discretion of the investigator).
4. Any systemic disease, autoimmune disease, or use of medication which may interfere with contact lens wear (at the discretion of the investigator).
5. Any infectious diseases (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (eg, HIV), by self-report.
6. Current habitual use of Restasis, Xiidra, ocular steroids, or any medication (RX or OTC) that may interfere with contact lens wear (at the discretion of the investigator).
7. Grade 2 or greater corneal staining or conjunctival injection on the FDA scale.
8. Clinically significant (Grade 3 or greater on the FDA scale) corneal edema, corneal vascularization, or any other abnormalities of the cornea (excluding corneal staining) which would contraindicate contact lens wear.
9. Clinically significant (Grade 3 or greater on the FDA scale) tarsal abnormalities which might interfere with contact lens wear.
10. Any active ocular abnormalities/conditions that may interfere with contact lens wear (at the discretion of the investigator).
11. Any corneal distortion due to previous rigid gas permeable lens wear, surgery or pathology.
12. History of any ocular or corneal surgery (eg, RK, PRK, LASIK).
13. Habitual contact lens wear modality as extended wear.
14. Participation in any pharmaceutical or medical device related clinical trial within 7 days prior to study enrollment.
15. History of binocular vision abnormality or strabismus.
16. Habitual wearers of rigid gas permeable lens within the past 3 months.
17. Employees of investigational clinic (investigator, coordinator, and technician etc.) or family members of employees of the investigational clinic by self-report
18 Years
69 Years
ALL
Yes
Sponsors
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Johnson & Johnson Vision Care, Inc.
INDUSTRY
Responsible Party
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Locations
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Southern California College of Optometry
Anaheim, California, United States
University of California, Berkeley School of Optometry
Berkeley, California, United States
Vue Optical Boutique
Jacksonville, Florida, United States
The Ohio State University
Columbus, Ohio, United States
University of Houston College of Optometry
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CR-6012
Identifier Type: -
Identifier Source: org_study_id
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