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OpenTrials
Completed

NCT Number: NCT01371539

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

The purpose of this study was to compare visual performance measures between two multifocal contact lenses on presbyopic wearers.

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Key information

Conditions

Myopia Eye Diseases Presbyopia Refractive Errors

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lotrafilcon B contact lens

Device

Commercially marketed, silicone hydrogel, multifocal contact lens for daily wear use.

Other names: AIR OPTIX AQUA MULTIFOCAL

Comfilcon A contact lens

Device

Commercially marketed (France), silicone hydrogel, multifocal contact lens for daily wear use.

Other names: Biofinity Multifocal

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

CIBA VISION

Industry

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jun 13, 2011
Registry last updated
Aug 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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