Clinical Comparison of Two Multifocal Contact Lenses Made of Silicone Hydrogel Materials

June 28, 2012 updated by: CIBA VISION
The purpose of this study was to compare visual performance measures between two multifocal contact lenses on presbyopic wearers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

109

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.
  • Spectacle add of +0.50 to +2.50 diopters (inclusive).
  • Currently wearing soft contact lenses at least 5 days per week and at least 8 hours per day.
  • Able to be fit in both eyes with soft multifocal lenses in available powers.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Eye injury or surgery within 12 weeks of enrollment in trial.
  • Currently enrolled in any clinical trial.
  • Astigmatism of 1.00 diopter or more.
  • Currently wearing excluded brands of multifocal lenses, as specified by protocol.
  • 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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Lotrafilcon B / Comfilcon A
Lotrafilcon B contact lenses worn first, with comfilcon A contact lenses worn second. Both products worn bilaterally on a daily wear basis for one week each.
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 (France), silicone hydrogel, multifocal contact lens for daily wear use.
Other Names:
  • Biofinity Multifocal
Other: Comfilcon A / Lotrafilcon B
Comfilcon A contact lenses worn first, with lotrafilcon B contact lenses worn second. Both products worn bilaterally on a daily wear basis for one week each.
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 (France), 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
Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity
Time Frame: 1 week
The participant read a Snellen chart at a 20-foot equivalent distance with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal distance eyesight. A positive logMAR value indicated poorer vision, and a negative value denoted better visual acuity.
1 week
Corrected Near Binocular Visual Measurement in Normal Illumination Reported as Binocular Near Visual Acuity
Time Frame: 1 week
The participant read a Snellen chart at 40 centimeters with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal near eyesight. A positive logMAR value indicated poorer vision, and a negative value denoted better visual acuity.
1 week

Collaborators and Investigators

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

Sponsor

CIBA VISION

Investigators

  • Study Director: Stacie Cummings, O.D., Alcon Research

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

June 1, 2011

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

June 9, 2011

First Submitted That Met QC Criteria

June 9, 2011

First Posted (Estimate)

June 13, 2011

Study Record Updates

Last Update Posted (Estimate)

August 3, 2012

Last Update Submitted That Met QC Criteria

June 28, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P-319-C-021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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