Multicenter Dispensing Study of Biofinity Lenses in Extended Range

Completed · Not applicable

Conditions studied: Myopia, Hyperopia

In brief

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.

Key facts

Study ID

NCT02060539

Run by

CooperVision, Inc.

People needed

19

Starts

2013-10-01

Expected to finish

2014-12-01

Last updated by the study team

2017-12-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• UC Berkeley Clinica Research Center — Berkeley, California, United States
• CORL, Indiana University School of Optometry — Indianapolis, Indiana, United States
• TERTC, University of Houston — Houston, Texas, United States
• CCLR, University of Waterloo — Waterloo, Ontario, Canada

Full record on ClinicalTrials.gov

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