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

Study Results

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Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Presbyopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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BIOFINITY® MF - AIR OPTIX® AQUA MF

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)

Group Type EXPERIMENTAL

BIOFINITY® MF - AIR OPTIX® AQUA MF

Intervention Type DEVICE

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)

BIOFINITY® MF - PUREVISION® MF

Intervention Type DEVICE

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)

BIOFINITY® MF - PUREVISION® MF

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)

Group Type ACTIVE_COMPARATOR

BIOFINITY® MF - AIR OPTIX® AQUA MF

Intervention Type DEVICE

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)

BIOFINITY® MF - PUREVISION® MF

Intervention Type DEVICE

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)

Interventions

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BIOFINITY® MF - AIR OPTIX® AQUA MF

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)

Intervention Type DEVICE

BIOFINITY® MF - PUREVISION® MF

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)

Intervention Type DEVICE

Other Intervention Names

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BIOFINITY® MULTIFOCAL AIR OPTIX® AQUA MULTIFOCAL BIOFINITY® MULTIFOCAL PUREVISION® MULTIFOCAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No