Assessing Fitting Guides in Alcon Multifocal Contact Lenses

Study Overview
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Brief Summary
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The purpose of this study is to compare an alternative fitting guide to a current fitting guide for optimizing contact lens parameters and determining contact lens prescription.

Official Title
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Assessing Fitting Guides in Alcon Multifocal Contact Lenses

Conditions
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Presbyopia, Refractive Errors

Intervention / Treatment
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* Device: Lotrafilcon B multifocal contact lenses
* Device: Nelfilcon A multifocal contact lenses
* Device: Delefilcon A multifocal contact lenses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sign informed consent; Normal eyes; Current full-time soft contact lens wearer needing presbyopia correction; Willing to wear lenses for a minimum of five days per week, six hours per day, and attend all study visits; Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the Investigator; Eye conditions (past or present) as specified in the protocol; Currently wearing Alcon multifocal (MF) contact lenses; Only one eye with functional vision; Contact lens wear in one eye only; Use of mechanical eyelid therapy or eyelid scrubs within 14 days before Visit 1 and not willing to discontinue during the study; Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AOA MF<br>Lotrafilcon B multifocal contact lenses worn bilaterally (in both eyes) for 10 ± 3 days | Device: Lotrafilcon B multifocal contact lenses<br>* Contact lenses for near, intermediate, and distance correction worn on a daily wear basis and cared for with participant's habitual lens care solution<br>* Other names: AIR OPTIX AQUA® Multifocal;|
| Experimental: DACP MF<br>Nelfilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days | Device: Nelfilcon A multifocal contact lenses<br>* Contact lenses for near, intermediate, and distance correction worn on a daily disposable basis (removed every night and discarded) with a new pair of study lenses every morning<br>* Other names: DAILIES® AquaComfort Plus® Multifocal;|
| Experimental: DT1 MF<br>Delefilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days | Device: Delefilcon A multifocal contact lenses<br>* Contact lenses for near, intermediate, and distance correction worn on a daily disposable basis (removed every night and discarded) with a new pair of study lenses every morning<br>* Other names: DAILIES TOTAL1® Multifocal;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Number of Trial Lenses Needed to Fit Each Eye | The Investigator used a multi-focal contact lens fitting guide to determine which study lens to fit | VIsit 1/Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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contact lenses, presbyopia, multifocal