Clinical Study of Approved and Investigational Contact Lenses
NCT ID: NCT02708524
Last Updated: 2016-11-09
Study Results
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View full resultsBasic Information
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COMPLETED
NA
554 participants
INTERVENTIONAL
2016-01-31
2016-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Senofilcon C Wearers
Senofilcon C Wearers will wear the Senofilcon C Contact Lenses as daily wear for 30 (-2/+6) days.
Senofilcon C Contact Lens
Comfilcon A Wearers
Comfilcon A Wearers will wear the Comfilcon A Contact Lens as daily wear for 30 (-2/+6) days.
Comfilcon A Contact Lens
Lotrafilcon B Wearers
Lotrafilcon B Wearers will wear the Lotrafilcon B Contact Lens as daily wear for 30 (-2/+6) days.
Lotrafilcon B Contact Lens
Samfilcon A Wearers
Samfilcon A Wearers will wear the Samfilcon A Contact Lens as daily wear for 30 (-2/+6) days.
Samfilcon A Contact Lens
Interventions
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Senofilcon C Contact Lens
Comfilcon A Contact Lens
Lotrafilcon B Contact Lens
Samfilcon A Contact Lens
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
3. The subject must be between 18 to 40 years of age at the time of consent.
4. The subject's spherical equivalent distance refraction must be in the range of -1.25 to -6.00 in each eye.
5. The subject's refractive cylinder must be ≤1.00D in each eye.
6. The subject must have best corrected visual acuity of 20/30 or better in each eye.
7. The subject must be a habitual frequent replacement (reusable) daily wear spherical silicone hydrogel soft contact lens wearer in both eyes.
8. The subject must be able to wear contact lenses for a minimum of 8 hours, 4 days per week.
9. The subject must have normal eyes (i.e., no ocular medications or infections of any type).
Exclusion Criteria
2. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
3. Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
4. Any known sensitive/allergic to Ingredients of OPTI-FREE® PureMoist® solution.
5. Any daily disposable, extended wear, monovision, toric or multi-focal contact lens correction.
6. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion.
7. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.)
8. Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.
9. Any ocular infection.
10. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
11. Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.
12. History of binocular vision abnormality or strabismus.
13. Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV), by self-report).
14. Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)
18 Years
40 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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Montgomery, Alabama, United States
Fruit Cove, Florida, United States
Jacksonville, Florida, United States
Jacksonville, Florida, United States
Longwood, Florida, United States
Tallahassee, Florida, United States
Tampa, Florida, United States
Roswell, Georgia, United States
Bloomington, Illinois, United States
East Lansing, Michigan, United States
Medina, Minnesota, United States
Closter, New Jersey, United States
Vestal, New York, United States
Granville, Ohio, United States
Jacksonville, Texas, United States
Salt Lake City, Utah, United States
Roanoke, Virginia, United States
West Allis, Wisconsin, United States
Countries
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Other Identifiers
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CR-5808
Identifier Type: -
Identifier Source: org_study_id