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Clinical Trials/NCT01371539
NCT01371539
Completed
Not Applicable

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

CIBA VISION0 sites109 target enrollmentJune 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Myopia
Sponsor
CIBA VISION
Enrollment
109
Primary Endpoint
Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
June 2011
End Date
August 2011
Last Updated
13 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
CIBA VISION
Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

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.

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