Evaluation of a New Daily Disposable Multifocal Contact Lens Design

Not Applicable

Completed

• Conditions: Presbyopia; Hyperopia; Refractive Error
• Interventions: Device: Delefilcon A multifocal contact lenses; Device: Lotrafilcon B multifocal contact lenses

• Registration Number: NCT01951573
• Lead Sponsor: Alcon Research

Brief Summary

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2013-09-24
• Study First Submitted QC: 2013-09-24
• Study First Posted: 2013-09-26
• Study Start: 2013-10
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2014-11
• Results First Submitted: 2014-11-24
• Results First Submitted QC: 2014-11-24
• Last Update Submitted: 2014-11-24
• Results First Posted: 2014-12-02
• Last Update Posted: 2014-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
AOAMF, then Delefilcon A MF	Delefilcon A multifocal contact lenses	Lotrafilcon B multifocal contact lenses first, followed by delefilcon A multifocal contact lenses. Each product worn bilaterally (ie, in both eyes) for 9-12 hours, with a 1-8 day washout separating the 2 wear periods.
Delefilcon A MF, then AOAMF	Delefilcon A multifocal contact lenses	Delefilcon A multifocal contact lenses first, followed by lotrafilcon B multifocal contact lenses. Each product worn bilaterally (ie, in both eyes) for 9-12 hours, with a 1-8 day washout separating the 2 wear periods.
AOAMF, then Delefilcon A MF	Lotrafilcon B multifocal contact lenses	Lotrafilcon B multifocal contact lenses first, followed by delefilcon A multifocal contact lenses. Each product worn bilaterally (ie, in both eyes) for 9-12 hours, with a 1-8 day washout separating the 2 wear periods.
Delefilcon A MF, then AOAMF	Lotrafilcon B multifocal contact lenses	Delefilcon A multifocal contact lenses first, followed by lotrafilcon B multifocal contact lenses. Each product worn bilaterally (ie, in both eyes) for 9-12 hours, with a 1-8 day washout separating the 2 wear periods.

Primary Outcome Measures

Name	Time	Method
High Contrast/High Illumination (HC/HI) Binocular Visual Acuity (VA) at Near	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 Outcome Measures

Name	Time	Method
HC/HI Binocular VA at Distance	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.
Over-refraction (OR) Monocular at Distance	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.