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 |
A Multi-Center Study Comparing the Clinical Performance of Two Silicone Hydrogel Lenses Over
1 Month of Daily Wear
1 Month of Daily Wear
Two-month, single masked, randomized, bilateral, crossover, 1-month of daily wear in each
study lens.
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
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