Clinical Evaluation of Biofinity Multifocal Compared With Air Optix Aqua Multifocal and With PureVision Multifocal (INNOVATION)

CooperVision

Status: Completed

Conditions: Presbyopia

Treatments: Device: BIOFINITY® MF - AIR OPTIX® AQUA MF; Device: BIOFINITY® MF - PUREVISION® MF

Study type: Interventional

Funder types: Industry

Identifiers

NCT01591499

2011-A00886-35

Details and patient eligibility

About

This is a prospective, multi-centre, randomised, single-blind, cross-over study to compare the BIOFINITY® MULTIFOCAL lens and respectively the AIR OPTIX® AQUA MULTIFOCAL lens (lenses allocated on a ratio of 1/0.5) and the PUREVISION® MULTIFOCAL lens (lenses allocated on a ratio of 1/0.5), in presbyopic patients.

Full description

This is a prospective, multi-centre, randomised, single-blind, cross-over study to compare the BIOFINITY® MULTIFOCAL lens and respectively the AIR OPTIX® AQUA MULTIFOCAL lens (lenses allocated on a ratio of 1/0.5) and the PUREVISION® MULTIFOCAL lens (lenses allocated on a ratio of 1/0.5), in presbyopic patients.

Each subject will have 5 visits with the investigator:

• (V1) An inclusion visit during which the first pair of lenses are fitted;
• (V2) An optimization visit after 7 to 9 days of wearing the first lens;
• (V3) An evaluation visit after an additional 10 to 15 days of wearing the first lens (17 to 24 days) and at which time the second pair of lenses are fitted;
• (V4, V5) Visits are conducted as in V 2 and V3 with the second pair of lenses.

Enrollment: 142 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female patients, aged 18 years or older
• Patients with proven presbyopia
• Patients who do not wear contact lenses or who wore spherical lenses before being included in the study
• Myopic patients whose spherical equivalent is less than or equal to 9.00 D (or a "lens" power less than or equal to -8,00 D) or hypermetropic patients whose spherical equivalent is less than or equal to +5.50 D (or a "lens" power less than or equal to +6,00 D) or emmetropic patients for distance vision (plan)
• Patient able to fill in a diary without help
• Patients who gave their informed consent to take part in the study

Exclusion criteria

• Patients with a contra-indication for wearing contact lenses
• Patients suffering from any ocular pathology that might interfere with the evaluation of the lenses
• Patients wearing multifocal lenses or spherical lenses for monovision before being included in the study
• Astigmatic patients whose cylinder is more than 0.75 D

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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142 participants in 2 patient groups

BIOFINITY® MF - AIR OPTIX® AQUA MF

Experimental group

Description:

During the first period, the participant will be allocated at random either the test lens pair (Biofinity) or a comparator lens pair (Air Optix or Purevision); during the second period, the participant will crossover to the alternate lens pair. (Biofinity crossover to Air Optix or Purevision) (Air Optix or Purevision crossover to Biofinity)

Treatment:

Device: BIOFINITY® MF - PUREVISION® MF

Device: BIOFINITY® MF - AIR OPTIX® AQUA MF

BIOFINITY® MF - PUREVISION® MF

Active Comparator group

Description:

During the first period, the participant will be allocated at random either the test lens pair (Biofinity) or a comparator lens pair (Air Optix or Purevision); during the second period, the participant will crossover to the alternate lens pair. (Biofinity crossover to Air Optix or Purevision) (Air Optix or Purevision crossover to Biofinity)

Treatment:

Device: BIOFINITY® MF - PUREVISION® MF

Device: BIOFINITY® MF - AIR OPTIX® AQUA MF