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

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

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.

Study Overview

• Status: Completed
• Conditions: Presbyopia
• Intervention / Treatment: Device: BIOFINITY® MF - AIR OPTIX® AQUA MF; Device: BIOFINITY® MF - PUREVISION® MF

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.

• Study Type: Interventional
• Enrollment (Actual): 142
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Performance - Near Visual Acuity	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	Measured at V3 or V5
Visual Performance - Distance Visual Acuity	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	Measure at V3 or V5
Visual Performance - Quality of Near Vision	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	Measured at V3 or V5
Visual Performance - Quality of Intermediate Vision	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	Measured at V3 or V5
Visual Performance - Quality of Distance Vision	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	Measured at 17-24 days V3 or V5
Visual Performance - Near, Low Contrast Vision	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	Measured at V3 or V5
Visual Performance: Near, High Contrast Vision	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	Measured at 17-24 days V3 or V5
Visual Performance: Distance, Low Contrast Vision	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	Measured at V3 or V5
Visual Performance: Distance, High Contrast Vision	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	Measured at V3 or V5
Visual Performance - Near Stereoscopic Vision	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	Measured at V3 or V5
Subjective Rating of Lens Comfort, Fitting	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	Measured at V3 or V5
Subjective Rating of Lens Comfort - During Day	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	Measured at V3 or V5
Subjective Rating of Lens Comfort - End of Day	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	Measured at V3 or V5
Subjective Rating of Lens Comfort - General Comfort	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	Measured at V3 or V5
Comfort of Use - Average Wearing Time	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)	Measured at V3 or V5
Geometric Performance - Lens Centration	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	Measured at V3 or V5
Geometric Performance - Lens Mobility	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	Measured at 17-24 days V3 or V5
Clinical Performance - Lens Wettability	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	Measured at 17-24 days V3 or V5
Lens Preference - Participant	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.	Measured at V5
Lens Preference - Ophthalmologist	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.	Measured at 17-24 days V3 or V5

Collaborators and Investigators

• Sponsor: Coopervision, Inc.
• Investigators: Study Director: Sandrine Cheneau, Coopervision, Inc.; Study Director: Caroline Bonneville, Coopervision, Inc.; Principal Investigator: Catherine Peyre, Catherine Peyre

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: March 19, 2012
• First Submitted That Met QC Criteria: May 2, 2012
• First Posted (Estimate): May 4, 2012

Study Record Updates

• Last Update Posted (Actual): August 11, 2020
• Last Update Submitted That Met QC Criteria: July 28, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia
• Other Study ID Numbers: 2011-A00886-35