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

Study Overview
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Brief Summary
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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.

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

Conditions
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Myopia, Ametropia, Presbyopia, Refractive Error

Intervention / Treatment
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* Device: Nelfilcon A multifocal contact lens with comfort additive
* Device: Nelfilcon A multifocal contact lens


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DAILIES® AquaComfort Plus® Multifocal<br>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<br> <br> |
| Active Comparator: Focus® DAILIES® Progressives<br>Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis | Device: Nelfilcon A multifocal contact lens<br> <br> |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myopia, Presbyopia, Refractive error, Contact lenses, Multifocal