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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Coopervision, Inc.
ClinicalTrials.gov Identifier:
NCT01591499
First received: March 19, 2012
Last updated: January 7, 2016
Last verified: January 2016
  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® MF - AIR OPTIX® AQUA MF
Device: BIOFINITY® MF - PUREVISION® MF
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 Performance - Comparison of Initial Refraction to Multifocal Lenses [ Time Frame: Change over time measured at V1, V3 and V5 ] [ Designated as safety issue: No ]

    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



Secondary Outcome Measures:
  • Visual Performance - Near Visual Acuity [ Time Frame: Measured at V3 or V5 ] [ Designated as safety issue: No ]

    Description: The participant's near binocular visual acuity (at 40 cm) using the Parinaud chart (smallest to largest letters, Score P1.5, P2, P4, P5) and reported per lens.

    Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):

    V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two


  • Visual Performance - Distance Visual Acuity [ Time Frame: Measure at V3 or V5 ] [ Designated as safety issue: No ]

    Description: The participant's distance binocular visual acuity (at 5 meters) using the La Galinet method. (Decimal scale, Excellent=between 5 and 20 tenths at 5 metres and between 1 and 20 tenths at 40 cm)

    Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):

    V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two


  • Visual Performance - Quality of Near Vision [ Time Frame: Measured at V3 or V5 ] [ Designated as safety issue: No ]

    Patients' subjective rating for quality of near vision by patient diary and reported per lens. (40cm away: reading a newspaper, looking at your watch etc. 0-100, 0=totally blurred, 100=perfectly clear).

    Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):

    V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two


  • Visual Performance - Quality of Intermediate Vision [ Time Frame: Measured at V3 or V5 ] [ Designated as safety issue: No ]

    Patients' subjective rating for quality of intermediate vision by patient diary and reported per lens. (distance equivalent to an arm's length. 0-100, 0=totally blurred, 100=perfectly clear).

    Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):

    V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two


  • Visual Performance - Quality of Distance Vision [ Time Frame: Measured at 17-24 days V3 or V5 ] [ Designated as safety issue: No ]

    Patients' subjective rating for quality of distance vision by patient diary and reported per lens. (driving, looking at a landscape, etc. 0-100, 0=totally blurred, 100=perfectly clear).

    Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):

    V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two


  • Visual Performance - Near, Low Contrast Vision [ Time Frame: Measured at V3 or V5 ] [ Designated as safety issue: No ]

    The number of letters read at a near of 40 centimeters under 10% low contrast. Measured by objective assessment and reported per lens. Rated on a visual chart (La Galinet- number of letters read).

    Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):

    V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two


  • Visual Performance: Near, High Contrast Vision [ Time Frame: Measured at 17-24 days V3 or V5 ] [ Designated as safety issue: No ]

    The number of letters read at a near of 40 centimeters under 90% high contrast. Measured by objective assessment and reported per lens. Rated on a visual chart (La Galinet- number of letters read).

    Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):

    V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two


  • Visual Performance: Distance, Low Contrast Vision [ Time Frame: Measured at V3 or V5 ] [ Designated as safety issue: No ]

    The number of letters read at a distance of 5 meters under 10% low contrast. Measured by objective assessment and reported per lens. Rated on a visual chart (La Galinet- number of letters read).

    Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):

    V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two


  • Visual Performance: Distance, High Contrast Vision [ Time Frame: Measured at V3 or V5 ] [ Designated as safety issue: No ]

    The number of letters read at a distance of 5 meters under 90% high contrast. Measured by objective assessment and reported per lens. Rated on a visual chart (La Galinet- number of letters read).

    Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):

    V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two


  • Visual Performance - Near Stereoscopic Vision [ Time Frame: Measured at V3 or V5 ] [ Designated as safety issue: No ]

    The mean number of occurrences where the "number of the last figure where the patient equipped with analyzers can make out the raised circle (from number 1 to 9)," performed at a distance of 40 centimeters, using Wirt Vectographic Stereopsis Test. Reported per lens.

    Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):

    V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two


  • Subjective Rating of Lens Comfort, Fitting [ Time Frame: Measured at V3 or V5 ] [ Designated as safety issue: No ]

    Patients' subjective rating for lens comfort by patient diary and reported per lens. (After lens fitting, Scale 0-100, 0=very uncomfortable, 100=very comfortable).

    Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):

    V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two


  • Subjective Rating of Lens Comfort - During Day [ Time Frame: Measured at V3 or V5 ] [ Designated as safety issue: No ]

    Patients' subjective rating for lens comfort by patient diary and reported per lens. (During the Day, Scale 0-100, 0=very uncomfortable, 100=very comfortable).

    Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):

    V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two


  • Subjective Rating of Lens Comfort - End of Day [ Time Frame: Measured at V3 or V5 ] [ Designated as safety issue: No ]

    Patients' subjective rating for lens comfort by patient diary and reported per lens. (At End of Day, Scale 0-100, 0=very uncomfortable, 100=very comfortable).

    Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):

    V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two


  • Subjective Rating of Lens Comfort - General Comfort [ Time Frame: Measured at V3 or V5 ] [ Designated as safety issue: No ]

    Patients' subjective rating for lens comfort by patient diary and reported per lens. (General Comfort, Scale 0-100, 0=very uncomfortable, 100=very comfortable).

    Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):

    V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two


  • Comfort of Use - Average Wearing Time [ Time Frame: Measured at V3 or V5 ] [ Designated as safety issue: No ]

    The average numbers of hours per day of lens wear by patient. Reported per lens. Calculated by number of hours worn.

    Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):

    V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two Patients' subjective rating for lens comfort of use by patient diary and reported per lens. (Average Wearing Time in hours per day)


  • Geometric Performance - Lens Centration [ Time Frame: Measured at V3 or V5 ] [ Designated as safety issue: No ]

    Description: The ophthalmologist's rating of lens centration during "Focus" and "Shift When Blinking" by questionnaire as a limited selected response (Optimal, Decentration Acceptable or Decentration Unacceptable). Assessed with the slit lamp and reported per lens.

    Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):

    V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two


  • Geometric Performance - Lens Mobility [ Time Frame: Measured at 17-24 days V3 or V5 ] [ Designated as safety issue: No ]

    The ophthalmologist's rating of lens movement during blinking by questionnaire as a limited selected response (Optimal, Acceptable with a tendency to be tight, Acceptable with a tendency to be Flat, Unacceptable and too tight, or Unacceptable too flat). Assessed with the slit-lamp and reported per lens.

    Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):

    V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two


  • Clinical Performance - Lens Wettability [ Time Frame: Measured at 17-24 days V3 or V5 ] [ Designated as safety issue: No ]

    The ophthalmologist's rating of lens wettability by questionnaire as a limited selected response (Zero, Low, Acceptable, Good or Excellent). Assessed with the slit lamp and reported per lens.

    Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):

    V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two


  • Lens Preference - Participant [ Time Frame: Measured at V5 ] [ Designated as safety issue: No ]

    The number of participants who preferred a lens pair rated by diary questionnaire with a limited selected response.("Which pair of lenses did you prefer? The first pair, the second pair). Reported per lens.

    Measured at completion of V5 (lens pair two evaluation). Both lenses have been worn. Total time since base line is 34-48 days.


  • Lens Preference - Ophthalmologist [ Time Frame: Measured at 17-24 days V3 or V5 ] [ Designated as safety issue: No ]

    Ophthalmologists preference in terms of lenses rated by questionnaire with a limited selected response. ("Choice of Lens? First pair of lenses, Second pair of lenses") (Biofinity, Air Optix, or Purevision)

    Measured at completion of V5 (lens pair two evaluation). Both lenses have been worn. Total time since base line is 34-48 days.



Enrollment: 142
Study Start Date: September 2011
Study Completion Date: September 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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)
Device: 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)
Other Names:
  • BIOFINITY® MULTIFOCAL
  • AIR OPTIX® AQUA MULTIFOCAL
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)
Other Names:
  • BIOFINITY® MULTIFOCAL
  • PUREVISION® MULTIFOCAL
Active Comparator: 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)
Device: 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)
Other Names:
  • BIOFINITY® MULTIFOCAL
  • AIR OPTIX® AQUA MULTIFOCAL
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)
Other Names:
  • BIOFINITY® MULTIFOCAL
  • PUREVISION® MULTIFOCAL

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Results First Received: December 30, 2013
Last Updated: January 7, 2016
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Additional relevant MeSH terms:
Presbyopia
Eye Diseases
Refractive Errors

ClinicalTrials.gov processed this record on February 11, 2016