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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Coopervision, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Coopervision, Inc.
ClinicalTrials.gov Identifier:
NCT01591499
First received: March 19, 2012
Last updated: September 7, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Presbyopia
Device: BIOFINITY® MULTIFOCAL - AIR OPTIX® AQUA MULTIFOCAL
Device: BIOFINITY® MULTIFOCAL - PUREVISION® MULTIFOCAL
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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)

Further study details as provided by Coopervision, Inc.:

Primary Outcome Measures:
  • Visual acuity [ Time Frame: 17-24 days ] [ Designated as safety issue: No ]
    Compare binocular diatance and near visual acuity measured by ophthalmologist, for both distance and near vision, obtained with BIOFINITY® MULTIFOCAL with that obtained with AIR OPTIX® AQUA MULTIFOCAL and PUREVISION® MULTIFOCAL.


Secondary Outcome Measures:
  • Vision measures [ Time Frame: 17-24 days ] [ Designated as safety issue: No ]
    1. quality of distance, near and intermediate range (computer work) vision, while driving at night, visual stability, presence of halos or double vision, as evaluated by patient;, 2. ease patient adjusts (simplicity evaluated by ophthalmologist and speed evaluated by patient); 3. comfort of use (ease of handling and comfort while wearing lenses) evaluated by patient, 4. contrast, near and distance vision, evaluated by ophthalmologist, 5. near stereoscopic vision, evaluated by ophthalmologist


Estimated Enrollment: 165
Study Start Date: September 2011
Estimated Study Completion Date: September 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: BIOFINITY® MULTIFOCAL - AIR OPTIX® AQUA MULTIFOCAL Device: BIOFINITY® MULTIFOCAL - AIR OPTIX® AQUA MULTIFOCAL
Both groups of patients use both lenses
Active Comparator: BIOFINITY® MULTIFOCAL - PUREVISION® MULTIFOCAL Device: BIOFINITY® MULTIFOCAL - PUREVISION® MULTIFOCAL
Both groups of patients use both lenses

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.

Two periods: a period during which the 1st lens evaluated is worn, with an optimisation period of 7 to 9 days followed by an evaluation phase lasting between 10 and 15 days; a period during which the 2nd lens evaluated is worn, with an optimisation period of 7 to 9 days followed by an evaluation phase lasting between 10 and 15 days. Total length of the study for a given patient: between 34 and 48 days.

Five visits with the investigator: inclusion visit (V.1) at the start of the 1st period of wearing the lens; optimisation visit for the 1st pair of lenses (V2); an evaluation visit after the 1st period (V3); an optimisation visit for the 2nd pair of lenses (V.4) and an evaluation visit after the 2nd period of wearing the lens (V.5).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01591499

Sponsors and Collaborators
Coopervision, Inc.
Investigators
Study Director: Sandrine Cheneau Coopervision, Inc.
Study Director: Caroline Bonneville Coopervision, Inc.
Principal Investigator: Catherine Peyre Catherine Peyre
  More Information

No publications provided

Responsible Party: Coopervision, Inc.
ClinicalTrials.gov Identifier: NCT01591499     History of Changes
Other Study ID Numbers: 2011-A00886-35
Study First Received: March 19, 2012
Last Updated: September 7, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Presbyopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on September 16, 2014