Multicenter Dispensing Study of Biofinity Lenses in Extended Range



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:12/13/2017
Start Date:October 2013
End Date:December 2014

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To obtain subjective and objective feedback on the clinical performance of Biofinity lenses
after at least two weeks daily wear in existing contact lens wearers compared with their
habitual lenses.


Inclusion Criteria:

- Has had an oculo-visual examination in the last two years

- Is at least 18 years of age and has full legal capacity to volunteer

- Has read and understood the information consent letter

- Is willing and able to follow instructions and maintain the appointment schedule

- Is correctable to a visual acuity of 20/50 or better (in at least one eye) with their
habitual vision correction

- Currently wears soft contact lenses

- They should require contact lens powers between -12.00 and -20.00D or between +8.00
and +15.00D

- Has clear corneas and no active ocular disease

- Demonstrates an acceptable fit with the study lenses.

Exclusion Criteria:

- Has any systemic disease affecting ocular health

- Is taking medication, such as antihistamine eye drops, oral and ophthalmic
betaadrenergic blockers (e.g. Propanolol, Timolol), anticholinergics, and any
prescribed or over-the-counter eye medication, except artificial tears or eye
lubricants

- Have any active ocular disease and/or infection that would contraindicate contact lens
wear.

- Active ocular disease is defined as infection or inflammation which requires
therapeutic treatment. Mild (i.e. not considered clinically relevant) lid
abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and
conjunctival staining and dry eye are not considered active ocular disease.
Neovascularization and corneal scars are the result of previous hypoxia, infection or
inflammation and are therefore not active.

- Has worn gas permeable contact lenses within the last month.

- Is aphakic

- Has undergone corneal refractive surgery.

- Is participating in any other type of clinical research study

- Female who is currently pregnant or is breast-feeding.
We found this trial at
4
sites
2240 Piedmont Avenue
Berkeley, California 94720
?
mi
from
Berkeley, CA
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4800 Calhoun Road
Houston, Texas 77204
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mi
from
Houston, TX
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800 Atwater Avenue
Indianapolis, Indiana 46266
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mi
from
Indianapolis, IN
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200 Columbia Street West
Waterloo, Ontario N2L 3G1
?
mi
from
Waterloo,
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