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OpenTrials
Completed

NCT Number: NCT01997216

Multifocal Lens Design Evaluation

The purpose of this study was to compare binocular high contrast, high illumination (HC/HI) visual acuity at near (40 centimeters) of new multifocal contact lenses against AIR OPTIX® AQUA MULTIFOCAL contact lenses when worn for 9 hours.

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Key information

Conditions

Refractive Error Eye Diseases Presbyopia Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Each participant was randomized to a specific sequence of lens wear, during which each lens type was worn bilaterally for 9 hours to compare performance characteristics.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Sign written Informed Consent document.
  • Have spectacles that provide acceptable vision and be willing to wear them if unable to wear the study lenses.
  • Be presbyopic with a spectacle add ≥ 0.50 diopter.
  • Currently wearing soft contact lenses at least 5 days a week.
  • Other protocol-specified inclusion criteria may apply

Exclusion criteria

  • Eye injury or surgery within 12 weeks of enrollment in this trial.
  • Pre-existing ocular irritation that would preclude contact lens fitting.
  • Currently enrolled in any clinical trial.
  • Evidence of systemic or ocular abnormality, infection, or disease which is likely to affect successful wear of contact lenses (for at least 9 hours) or use of their accessory solutions as determined by the Investigator.
  • Any use of medications for which contact lens wear could be contraindicated as determined by the Investigator.
  • Binocular visual acuity worse than 20/25.
  • Corrected by monovision.
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

Delefilcon A multifocal contact lens

Device

Investigational silicone hydrogel contact lens dispensed in low, medium, or high ADD per current AIR OPTIX® AQUA MULTIFOCAL fitting guidelines

Lotrafilcon B multifocal contact lens

Device

Commercially marketed silicone hydrogel contact lens dispensed in low, medium, or high ADD per current AIR OPTIX® AQUA MULTIFOCAL fitting guidelines

Other names: AIR OPTIX® AQUA MULTIFOCAL, AOAMF

Primary outcomes

  1. Mean Binocular HC/HI Visual Acuity at Near (40 cm)

    Time frame: Up to Hour 9

    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 equates to a logMAR acuity of 0.0 and is considered normal near eyesight. A negative logMAR value denotes better visual acuity.

Secondary outcomes

  1. Mean Binocular HC/HI Visual Acuity at Distance

    Time frame: Up to Hour 9

    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 equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. A negative logMAR value denotes better visual acuity.

  2. Mean Monocular Over-refraction (OR) at Distance

    Time frame: Up to Hour 9

    OR is the amount of additional correction needed to improve visual acuity (VA). The OR at dispense was conducted with non-study product to determine lens power for the 9-hour wear. Dispensing of the study product (Pair 1 and Pair 2) was dependent upon lens power as determined by OR and resultant product availability. The OR at 9 hours was conducted with study product. All OR data is reported regardless whether study product was dispensed. Each eye contributed to the mean.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Multifocal Lens Design Evaluation (US)

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Nov 28, 2013
Registry last updated
Feb 4, 2014

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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