Clinical Evaluation of the Safety and Efficacy of a New Multifocal Contact Lens

The purpose of this study was to demonstrate substantial equivalence of the new DAILIES® AquaComfort Plus® Multifocal (DACP MF) contact lens to the commercially available Focus® DAILIES® Progressives (FDP) contact lens.

Study Overview

• Status: Completed
• Conditions: Refractive Error; Presbyopia; Myopia; Ametropia
• Intervention / Treatment: Device: Nelfilcon A multifocal contact lens with comfort additive; Device: Nelfilcon A multifocal contact lens

• Study Type: Interventional
• Enrollment (Actual): 83
• 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:

• Sign Informed Consent Document.
• Presbyopic and require a spectacle add of up to and including 3.00 diopters (D).
• Currently wear soft contact lenses.
• Willing and able to wear multifocal contact lenses in both eyes within the available range of powers for this trial and comply with the wearing and replacement schedule.
• Manifest cylinder less than or equal to 1.00 D.
• Able to achieve best corrected visual acuity (BCVA) of 20/25 or better (Snellen) in each eye at distance (as determined by manifest refraction).
• Able to achieve distance visual acuity of 20/40 (Snellen) or better in each eye with study lenses and deem subjective vision as satisfactory at time of dispense.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear within 6 months prior to enrollment.
• Any use of systemic or ocular medications for which contact lens wear could be contraindicated.
• History of corneal or refractive surgery.
• Biomicroscopy findings greater than Grade 2 at baseline.
• A pathologically dry eye that precludes contact lens wear.
• Monocular (only one eye with functional vision).
• Wear habitual contact lenses on an extended wear schedule (any number of nights of overnight wear on a regular basis).
• History of intolerance or hypersensitivity to any component of the investigational products.
• Concurrent participation in a contact lens or contact lens care product clinical trial or within the previous 30 days.
• Eye injury or ocular or intra-ocular surgery within 6 months prior to enrollment.
• Other protocol-defined exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DAILIES® AquaComfort Plus® Multifocal; Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis	Device: Nelfilcon A multifocal contact lens with comfort additive
Active Comparator: Focus® DAILIES® Progressives; Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis	Device: Nelfilcon A multifocal contact lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Overall Vision	The participant was instructed to, "Please rate the aggregate of distance, intermediate, and near vision quality. Fill in the circle below the number that indicates your selection. Rate eyes together, marking only 1 circle for both eyes. Higher numbers mean better vision." The response was recorded on a continuous scale from 1-10 (1=poor, 10=excellent).	Up to Day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Binocular Snellen Visual Acuity (VA) at Distance With Study Lenses	Visual Acuity was tested while reading a chart at 20-foot equivalent distance from the participant with both eyes together. The Snellen fraction compares the participant's result to the result expected from the 'normal' visual system. The numerator represents the distance between the participant and the chart, and the denominator represents the distance at which a person with 'normal' vision would be able to discern the same letter size. 20/20 is considered to be 'normal' vision, whereas visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. A larger denominator, therefore, indicates a lower visual acuity.	Up to Day 30
Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses	Visual Acuity was tested while reading charts at a distance of 40 cm from the participant with both eyes together. The Snellen fraction 20/20 represents 'normal' near vision. A larger denominator indicates a lower visual acuity.	Up to Day 30

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Justin Webb, O.D., Alcon Research

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: February 21, 2013
• First Submitted That Met QC Criteria: February 21, 2013
• First Posted (Estimate): February 25, 2013

Study Record Updates

• Last Update Posted (Estimate): May 23, 2014
• Last Update Submitted That Met QC Criteria: April 25, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Myopia; Presbyopia; Refractive error; Contact lenses; Multifocal
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia; Myopia
• Other Study ID Numbers: C-12-054