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

NCT01591499 | Completed Results

• 1 other identifier: 2011-A00886-35
• Study Type: interventional
• Target: 142
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Presbyopia

Outcome Measures

Primary Outcomes (1)

• Visual Performance - Comparison of Initial Refraction to Multifocal Lenses

  The percentage of participants who obtained binocular distance and near visual acuities (VA) at least as good as their initial refraction assessment. Measured by Initial Refraction. Distance binocular VA (at 5 meters) using the Snellen chart decimal scale and near binocular VA (at 40 cm) using the Parinaud chart (smallest to largest letters, Score P1.5, P2, P4, P5). Change over time measured at V1 (initial refraction) and at V3 (lens pair one evaluation) and V5 (lens pair two evaluation): V1 = initial refraction at baseline, V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two

  Change over time measured at V1, V3 and V5

Secondary Outcomes (20)

• Visual Performance - Near Visual Acuity

  Measured at V3 or V5

• Visual Performance - Distance Visual Acuity

  Measure at V3 or V5

• Visual Performance - Quality of Near Vision

  Measured at V3 or V5

• Visual Performance - Quality of Intermediate Vision

  Measured at V3 or V5

• Visual Performance - Quality of Distance Vision

  Measured at 17-24 days V3 or V5

Study Arms (2)

BIOFINITY® MF - AIR OPTIX® AQUA MF

EXPERIMENTAL

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)

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

BIOFINITY® MF - PUREVISION® MF

ACTIVE COMPARATOR

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)

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

Interventions

BIOFINITY® MF - AIR OPTIX® AQUA MF 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)

Also known as: BIOFINITY® MULTIFOCAL, AIR OPTIX® AQUA MULTIFOCAL

BIOFINITY® MF - AIR OPTIX® AQUA MF; BIOFINITY® MF - PUREVISION® MF

BIOFINITY® MF - PUREVISION® MF 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)

Also known as: BIOFINITY® MULTIFOCAL, PUREVISION® MULTIFOCAL

BIOFINITY® MF - AIR OPTIX® AQUA MF; BIOFINITY® MF - PUREVISION® MF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CooperVision, Inc.: lead

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Caroline Bonneville and Sandrine Cheneau, Study Managers
• Organization: CooperVision

caroline.bonneville@coopervision-fr.com

+33609202762

Study Officials

• Sandrine Cheneau

  CooperVision, Inc.

  STUDY DIRECTOR

• Caroline Bonneville

  CooperVision, Inc.

  STUDY DIRECTOR

• Catherine Peyre

  Catherine Peyre

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2012
• First Posted: May 4, 2012
• Study Start: September 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: September 1, 2012
• Last Updated: August 11, 2020
• Results First Posted: February 8, 2016

Record last verified: 2020-07