A Multi-Center Study Comparing the Clinical Performance of Two Silicone Hydrogel Lenses Over 1 Month of Daily Wear



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - 40
Updated:4/21/2016
Start Date:October 2013
End Date:March 2014

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A Multi-Center Study Comparing the Clinical Performance of Two Silicone Hydrogel Lenses Over
1 Month of Daily Wear

Two-month, single masked, randomized, bilateral, crossover, 1-month of daily wear in each
study lens.

Inclusion Criteria:

- Is between 18 and 40 years of age (inclusive)

- Have the use of a mobile phone to send and receive text messages throughout the day
for the duration of the study

- Has had a self-reported visual exam in the last two years

- Is an adapted soft CL wearer

- Has a Contact Lens (CL) spherical prescription between - 1.00 and - 9.00 (inclusive)

- Has less than 0.75D spectacle cylinder in each eye

- Is correctable to a visual acuity of 20/25 or better in both eyes

- Has clear corneas and no active ocular disease

- Has read, understood and signed the information consent letter

- Is willing to comply with the wear schedule (at least 40 hrs per week)

- Is willing to comply with the visit schedule

Exclusion Criteria:

- Has never worn contact lenses before

- Currently wears rigid gas permeable contact lenses

- Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)

- Has a contact lens prescription outside the range of - 1.00 to -9.00D

- Has a spectacle cylinder greater than -0.50D of cylinder in either eye

- Has best corrected spectacle distance vision worse then 20/25 in either eye

- Has any systemic disease affecting ocular health

- Is using any systemic or topical medications that will affect ocular health

- Has any ocular pathology or severe insufficiency of lacrimal secretion

- Has persistent, clinically significant corneal or conjunctival staining

- Has active neovascularization or any central corneal scars

- Is aphakic

- Is presbyopic

- Has undergone corneal refractive surgery

- Is participating in any other type of eye related clinical or research study
We found this trial at
6
sites
Medina, Minnesota 55340
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Medina, MN
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Athens, Georgia 45701
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Athens, GA
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Campbell, California 95008
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Campbell, CA
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Oak Lawn, Illinois 60453
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Oak Lawn, IL
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Pittsburg, Kansas 66762
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Pittsburg, KS
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Whittier, California 90606
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Whittier, CA
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