Multicenter Dispensing Study of Biofinity Lenses in Extended Range

CooperVision

Status: Completed

Conditions: Myopia; Hyperopia

Treatments: Device: Biofinity XR

Study type: Interventional

Funder types: Industry

Identifiers

NCT02060539

CV-13-47

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

Biofinity XR

Experimental group

Description:

Participants dispensed Biofinity XR lenses over two weeks of lens wear

Treatment:

Device: Biofinity XR