Multi-Center 2-Week Clinical Evaluation of Three Silicone Hydrogel Contact Lenses
NCT ID: NCT01244516
Last Updated: 2018-06-19
Study Results
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View full resultsBasic Information
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COMPLETED
NA
540 participants
INTERVENTIONAL
2010-09-01
2010-11-01
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
SINGLE
Study Groups
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galyfilcon A
Subjects that were randomized to receive the galyfilcon A lens with a base curve of 8.30 throughout the entire course of the study.
galyfilcon A, BC 8.30
galyfilcon A, BC 8.30 soft contact lens
lotrafilcon B
Subjects that were randomized to wear lotrafilcon B lens throughout the course of the study.
lotrafilcon B, BC 8.60
lotrafilcon B, BC 8.60 soft contact lens
comfilcon A
Subjects that were randomized to wear comfilcon A lens throughout the course of the study.
comfilcon A, BC 8.60
comfilcon A, BC 8.60 soft contact lens
Interventions
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galyfilcon A, BC 8.30
galyfilcon A, BC 8.30 soft contact lens
lotrafilcon B, BC 8.60
lotrafilcon B, BC 8.60 soft contact lens
comfilcon A, BC 8.60
comfilcon A, BC 8.60 soft contact lens
Eligibility Criteria
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Inclusion Criteria
* Sign Written Informed Consent and investigator to record this on Case Report Form.
* Be willing and able to adhere to the instructions set out in the protocol.
* Be an existing successful daily wear soft contact lens wearer. For the purposes of this study this means wearing lenses for at least 6 hours per day, 5 days per week for the last month.
* No extended wear in the last 3 months.
* Subjective refraction must result in a vertex corrected spherical contact lens prescription between -1.00 and -6.00 diopters.
* Have refractive astigmatism less than or equal to 1.00 diopters (D) in both eyes.
* Achieve visual acuity of 6/9 (20/30) or better in each eye.
* Require a visual correction in both eyes (no monovision allowed).
* Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having: no amblyopia, no evidence of lid abnormality or infection (including blepharitis/meibomitis), no conjunctival abnormality or infection, no clinically significant slit lamp findings (i.e. stromal edema, vascularization, infiltrates or abnormal opacities), no other active ocular disease.
Exclusion Criteria
* Clinically significant corneal stromal haze, corneal vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear.
* Clinically significant corneal staining
* Requires presbyopic correction (i.e. Not using any presbyopic correction and measured add power of less than +1.00 diopters).
* Has had refractive surgery.
* Has had eye injury/surgery within 8 weeks immediately prior to enrollment for this study.
* Abnormal lacrimal secretions.
* Pre-existing ocular irritation that would preclude contact lens fitting.
* Keratoconus or other corneal irregularity.
* Hard, hybrid or Rigid Gas Permeable lens wear in the previous 8 weeks.
* Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
* Diabetic.
* Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease \[e.g., Human immunodeficiency virus (HIV)\].
* History of chronic eye disease (e.g. glaucoma or Age Related Macular Degeneration).
* Pregnancy, lactating or planning a pregnancy at the time of enrollment.
* Participation in any concurrent clinical trial or in last 30 days
18 Years
39 Years
ALL
No
Sponsors
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Johnson & Johnson Vision Care, Inc.
INDUSTRY
Responsible Party
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Locations
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Brea, California, United States
Campbell, California, United States
Cupertino, California, United States
Mission Viejo, California, United States
Colorado Springs, Colorado, United States
Bridgeport, Connecticut, United States
Aventura, Florida, United States
Jacksonville, Florida, United States
Tallahassee, Florida, United States
Tampa, Florida, United States
Winter Park, Florida, United States
Roswell, Georgia, United States
Bloomington, Illinois, United States
Mishawaka, Indiana, United States
Pittsburg, Kansas, United States
Boston, Massachusetts, United States
Independence, Missouri, United States
Raytown, Missouri, United States
Closter, New Jersey, United States
New York, New York, United States
Raleigh, North Carolina, United States
North Olmsted, Ohio, United States
Powell, Ohio, United States
Kittanning, Pennsylvania, United States
Warwick, Rhode Island, United States
Chamberlain, South Dakota, United States
Bartlett, Tennessee, United States
Brentwood, Tennessee, United States
Memphis, Tennessee, United States
Tyler, Texas, United States
Tyler, Texas, United States
Salt Lake City, Utah, United States
Burlington, Vermont, United States
Salem, Virginia, United States
Virginia Beach, Virginia, United States
Countries
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Other Identifiers
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CR-201007
Identifier Type: -
Identifier Source: org_study_id
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