Overview

This trial is active, not recruiting.

Condition presbyopia
Treatments biofinity® multifocal - air optix® aqua multifocal, biofinity® multifocal - purevision® multifocal
Phase phase 4
Sponsor Coopervision, Inc.
Start date September 2011
End date May 2012
Trial size 165 participants
Trial identifier NCT01591499, 2011-A00886-35

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Active Comparator)
biofinity® multifocal - air optix® aqua multifocal
Both groups of patients use both lenses
(Active Comparator)
biofinity® multifocal - purevision® multifocal
Both groups of patients use both lenses

Primary Outcomes

Measure
Visual acuity
time frame: 17-24 days

Secondary Outcomes

Measure
Vision measures
time frame: 17-24 days

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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)
Principal investigator Catherine Peyre
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).
Trial information was received from ClinicalTrials.gov and was last updated in September 2012.
Information provided to ClinicalTrials.gov by Coopervision, Inc..