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Completed

NCT Number: NCT01951573

Evaluation of a New Daily Disposable Multifocal Contact Lens Design

The purpose of this study is to demonstrate non-inferiority of a new daily disposable multifocal contact lens in plus powers against the commercially available AIR OPTIX® AQUA MULTIFOCAL (AOAMF) lens in high contrast/high illumination (HC/HI) near visual acuity (VA).

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Key information

Conditions

Presbyopia Eye Diseases Hyperopia Refractive Error Refractive Errors

Age range

18 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

  • Subjects with normal eyes who are not using any ocular medication.
  • Must sign the Informed Consent document.
  • Habitual lens power within the range available for the study lenses (+1.00 to +3.50 diopters(D)).
  • Manifest cylinder less than or equal to 0.75D.
  • Best corrected distance VA greater than or equal to 20/25 in each eye.
  • Existing soft contact lens (CL) wearers who wear contact lenses in both eyes at least 5 days per week.
  • Presbyopic with a spectacle addition (ADD) >0.50D and <2.75D.
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

  • Any ocular disease, inflammation, or abnormality that contraindicates CL wear.
  • Any use of systemic or ocular medications for which CL wear could be contraindicated.
  • History of herpetic keratitis.
  • History of refractive surgery or irregular cornea.
  • A clinically significant dry eye that precludes CL wear.
  • Participation of the subject in a clinical study (including CL or CL care product) within the previous 30 days.
  • Monocular (only 1 eye with functional vision).
  • History of intolerance or hypersensitivity to any component of the test articles.
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

Delefilcon A multifocal contact lenses

Device

Silicone hydrogel multifocal contact lenses for daily wear, daily disposable use

Lotrafilcon B multifocal contact lenses

Device

Silicone hydrogel multifocal contact lenses with a labeled indication for daily wear and extended wear use of up to 6 days with monthly replacement

Other names: AIR OPTIX® AQUA MULTIFOCAL

Primary outcomes

  1. High Contrast/High Illumination (HC/HI) Binocular Visual Acuity (VA) at Near

    Time frame: Dispense (Day 1), Hour 9

    Near VA was assessed binocularly (both eyes together) at 40 centimeters, with over-refraction (OR), if necessary, and measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity.

Secondary outcomes

  1. HC/HI Binocular VA at Distance

    Time frame: Dispense (Day 1), Hour 9

    Distance VA was assessed binocularly (both eyes together) at 6 meters, with over-refraction (OR), if necessary, and measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity.

  2. Over-refraction (OR) Monocular at Distance

    Time frame: Dispense (Day 1), Hour 9

    OR (the amount of additional correction needed to improve VA) at distance (equivalent to 6 meters) was assessed monocularly (for each eye separately) in diopters (D). Both eyes contributed to the mean.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Delefilcon A Multifocal Plus Power Lens Design Evaluation

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Sep 26, 2013
Registry last updated
Dec 2, 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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