CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 142 enrolled
Drug / intervention
BIOFINITY® MF - AIR OPTIX® AQUA MF +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01591499
NCT01591499N/ACompleted

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

CooperVision, Inc.·interventional·Posted May 4, 2012·Updated Aug 11, 2020

In Brief

A clinical study evaluating BIOFINITY® MF - AIR OPTIX® AQUA MF and BIOFINITY® MF - PUREVISION® MF for Presbyopia. Completed, enrolled 142 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPresbyopia
Countries--
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 4, 2012
Enrollment StartSep 1, 2011
Primary CompletionDec 1, 2011
Study CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 14.2 years ago

Interventions

BIOFINITY® MF - AIR OPTIX® AQUA MFdevice

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)

BIOFINITY® MF - PUREVISION® MFdevice

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)