Multi-Center 2-Week Clinical Evaluation of Three Silicone Hydrogel Contact Lenses



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - 39
Updated:6/21/2018
Start Date:September 1, 2010
End Date:November 1, 2010

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The purpose of this study is to compare the clinical performance of three silicone hydrogel
contact lenses over a 2 week period.


Inclusion Criteria:

- Be no less than 18 and no more than 39 years of age.

- 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:

- Requires concurrent ocular medication.

- 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
We found this trial at
34
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Virginia Beach, VA
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Aventura, FL
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Bartlett, TN
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Bloomington, IL
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Boston, MA
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12
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Brea, CA
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Brentwood, TN
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Bridgeport, CT
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Burlington, VT
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313
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Campbell, CA
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Chamberlain, South Dakota 57325
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Chamberlain, SD
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Closter, NJ
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Colorado Springs, Colorado 80910
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Colorado Springs, CO
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318
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Cupertino, CA
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1350
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Independence, MO
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Jacksonville, FL
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Kittanning, PA
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Memphis, TN
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1802
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Mishawaka, IN
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Mission Viejo, California 92691
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Mission Viejo, CA
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2435
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New York, NY
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2020
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North Olmsted, OH
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1323
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Pittsburg, KS
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1957
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Powell, OH
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2214
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Raleigh, NC
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1346
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Raytown, MO
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Roswell, GA
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2126
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Salem, VA
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570
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Salt Lake City, UT
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1977
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Tallahassee, FL
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Tampa, FL
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1315
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Tyler, TX
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Warwick, RI
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2184
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Winter Park, FL
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