Comparison of Two Multifocal Contact Lenses

June 26, 2012 updated by: CIBA VISION
The purpose of this study is to compare two multifocal contact lenses in presbyopic wearers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • At least 35 years of age.
  • Sign written Informed Consent
  • Spectacle add of +0.50 to +2.50D.
  • Best corrected visual acuity of at least 20.30 in both eyes.
  • Currently wearing soft contact lenses at least 5 days per week.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Eye injury or surgery within twelve weeks of enrollment.
  • Currently enrolled in any clinical trial.
  • Astigmatism > 1.00D.
  • Strabismus/amblyopia.
  • Other protocol-defined exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Lotrafilcon B / Comfilcon A
Lotrafilcon B multifocal contact lenses worn first, with comfilcon A multifocal contact lenses worn second. Each product worn bilaterally on a daily wear basis for one week.
Device: Lotrafilcon B contact lens
Commercially marketed, silicone hydrogel, multifocal contact lens for daily wear use
Other Names:
  • AIR OPTIX AQUA MULTIFOCAL
Device: Comfilcon A contact lens
Commercially marketed (Europe), silicone hydrogel, multifocal contact lens for daily wear use
Other Names:
  • BIOFINITY MULTIFOCAL
OTHER: Comfilcon A /Lotrafilcon B
Comfilcon A multifocal contact lenses worn first, with lotrafilcon B multifocal contact lenses worn second. Each product worn bilaterally on a daily wear basis for one week.
Device: Lotrafilcon B contact lens
Commercially marketed, silicone hydrogel, multifocal contact lens for daily wear use
Other Names:
  • AIR OPTIX AQUA MULTIFOCAL
Device: Comfilcon A contact lens
Commercially marketed (Europe), silicone hydrogel, multifocal contact lens for daily wear use
Other Names:
  • BIOFINITY MULTIFOCAL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Vision
Time Frame: One week of wear
Overall vision, as interpreted by the participant and recorded by the investigator as a single, retrospective evaluation of one week's wear time. Overall vision was measured on a 10-point scale, with 1 being worst and 10 being best.
One week of wear

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CIBA VISION

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (ACTUAL)

October 1, 2010

Study Completion (ACTUAL)

October 1, 2010

Study Registration Dates

First Submitted

November 29, 2010

First Submitted That Met QC Criteria

November 29, 2010

First Posted (ESTIMATE)

November 30, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

June 29, 2012

Last Update Submitted That Met QC Criteria

June 26, 2012

Last Verified

July 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P-319-C-018

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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