Clinical Validation of Biofinity Toric MTO (Made To Order) Lenses

CooperVision

Status: Completed

Conditions: Myopia; Astigmatism

Treatments: Device: comfilcon A; Device: comfilcon A MTO

Study type: Interventional

Funder types: Industry

Identifiers

NCT02185105

CV-14-04

Details and patient eligibility

About

The study hypothesis is there is no difference in the clinical performance between the test and control lenses, in particular in lens stability, toric mislocation, comfort ratings and anterior segment ocular health findings.

Full description

Evaluate the clinical performance of Biofinity toric MTO lenses against current commercial Biofinity toric lenses over 6 hours of lens wear.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has had a self-reported 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 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
• Currently wears soft contact lenses.
• Has clear corneas and no active ocular disease.
• Has not worn lenses for at least 12 hours before the examination

Exclusion criteria

• Has never worn contact lenses before.
• 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 (moderate to severe dry eyes) that would affect the wearing of contact lenses.
• Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
• Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
• Is aphakic.
• Has undergone corneal refractive surgery.
• Is participating in any other type of eye related clinical or research study.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

comfilcon A MTO

Experimental group

Description:

Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.

Treatment:

Device: comfilcon A

comfilcon A

Active Comparator group

Description:

Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.

Treatment:

Device: comfilcon A MTO