Evaluation of a New Daily Disposable Multifocal Contact Lens Design

Delefilcon A Multifocal Plus Power Lens Design Evaluation

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).

Study Overview

• Status: Completed
• Conditions: Refractive Error; Presbyopia; Hyperopia
• Intervention / Treatment: Device: Delefilcon A multifocal contact lenses; Device: Lotrafilcon B multifocal contact lenses

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Delefilcon A MF, then AOAMF; 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.	Device: Delefilcon A multifocal contact lenses; Silicone hydrogel multifocal contact lenses for daily wear, daily disposable use; Device: Lotrafilcon B multifocal contact lenses; 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
OTHER: AOAMF, then Delefilcon A MF; 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.	Device: Delefilcon A multifocal contact lenses; Silicone hydrogel multifocal contact lenses for daily wear, daily disposable use; Device: Lotrafilcon B multifocal contact lenses; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
High Contrast/High Illumination (HC/HI) Binocular Visual Acuity (VA) at Near	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.	Dispense (Day 1), Hour 9

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HC/HI Binocular VA at Distance	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.	Dispense (Day 1), Hour 9
Over-refraction (OR) Monocular at Distance	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.	Dispense (Day 1), Hour 9

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Joachim Nick, Dipl. Ing., CIBA VISION GmbH

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (ACTUAL): November 1, 2013
• Study Completion (ACTUAL): November 1, 2013

Study Registration Dates

• First Submitted: September 24, 2013
• First Submitted That Met QC Criteria: September 24, 2013
• First Posted (ESTIMATE): September 26, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): December 2, 2014
• Last Update Submitted That Met QC Criteria: November 24, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: presbyopia; contact lenses; multifocal; daily disposable; silicone hydrogel
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia; Hyperopia
• Other Study ID Numbers: C-13-011