Clinical trial NCT01591499: Clinical Evaluation of Biofinity Multifocal Compared With Air Optix Aqua Multifocal and With PureVision Multifocal
Official title: Clinical Evaluation of the Biofinity Multifocal Lens Compared With the Air Optix Aqua Multifocal Lens and With PureVision Multifocal Lens (INNOVATION PRESBYOPIA Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2012-05-04
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual Performance - Comparison of Initial Refraction to Multifocal Lenses
timeFrame: Change over time measured at V1, V3 and V5
Secondary outcomes:
measure: Visual Performance - Near Visual Acuity
timeFrame: Measured at V3 or V5
measure: Visual Performance - Distance Visual Acuity
timeFrame: Measure at V3 or V5
measure: Visual Performance - Quality of Near Vision
timeFrame: Measured at V3 or V5
measure: Visual Performance - Quality of Intermediate Vision
timeFrame: Measured at V3 or V5
measure: Visual Performance - Quality of Distance Vision
timeFrame: Measured at 17-24 days V3 or V5
measure: Visual Performance - Near, Low Contrast Vision
timeFrame: Measured at V3 or V5
measure: Visual Performance: Near, High Contrast Vision
timeFrame: Measured at 17-24 days V3 or V5
measure: Visual Performance: Distance, Low Contrast Vision
timeFrame: Measured at V3 or V5
measure: Visual Performance: Distance, High Contrast Vision
timeFrame: Measured at V3 or V5
measure: Visual Performance - Near Stereoscopic Vision
timeFrame: Measured at V3 or V5
measure: Subjective Rating of Lens Comfort, Fitting
timeFrame: Measured at V3 or V5
measure: Subjective Rating of Lens Comfort - During Day
timeFrame: Measured at V3 or V5
measure: Subjective Rating of Lens Comfort - End of Day
timeFrame: Measured at V3 or V5
measure: Subjective Rating of Lens Comfort - General Comfort
timeFrame: Measured at V3 or V5
measure: Comfort of Use - Average Wearing Time
timeFrame: Measured at V3 or V5
measure: Geometric Performance - Lens Centration
timeFrame: Measured at V3 or V5
measure: Geometric Performance - Lens Mobility
timeFrame: Measured at 17-24 days V3 or V5
measure: Clinical Performance - Lens Wettability
timeFrame: Measured at 17-24 days V3 or V5
measure: Lens Preference - Participant
timeFrame: Measured at V5
measure: Lens Preference - Ophthalmologist
timeFrame: Measured at 17-24 days V3 or V5
Other outcomes:
Locations:
Study officials:
affiliation: CooperVision, Inc.
name: Sandrine Cheneau
role: STUDY_DIRECTOR
affiliation: CooperVision, Inc.
name: Caroline Bonneville
role: STUDY_DIRECTOR
affiliation: Catherine Peyre
name: Catherine Peyre
role: PRINCIPAL_INVESTIGATOR
References: