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

Not Applicable

Completed

• Conditions: Presbyopia; Myopia; Ametropia; Refractive Error
• Interventions: Device: Nelfilcon A multifocal contact lens with comfort additive; Device: Nelfilcon A multifocal contact lens

• Registration Number: NCT01797783
• Lead Sponsor: Alcon Research

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-21
• Study First Submitted QC: 2013-02-21
• Study First Posted: 2013-02-25
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2014-04
• Results First Submitted: 2014-04-25
• Results First Submitted QC: 2014-04-25
• Last Update Submitted: 2014-04-25
• Results First Posted: 2014-05-23
• Last Update Posted: 2014-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DAILIES® AquaComfort Plus® Multifocal	Nelfilcon A multifocal contact lens with comfort additive	Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
Focus® DAILIES® Progressives	Nelfilcon A multifocal contact lens	Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis

Primary Outcome Measures

Name	Time	Method
Subjective Overall Vision	Up to Day 30	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).

Secondary Outcome Measures

Name	Time	Method
Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses	Up to Day 30	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.
Binocular Snellen Visual Acuity (VA) at Distance With Study Lenses	Up to Day 30	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.