DAILIES® AquaComfort Plus® Multifocal (MF) - Comparative Assessment of Visual Performance

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2015-07-31

Brief Summary

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The purpose of this study is to evaluate the visual performance of DACP MF and PROCLEAR 1D MF daily disposable contact lenses in an established presbyopic population.

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Detailed Description

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Conditions

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Presbyopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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DACP MF, then PROCLEAR 1D MF

DACP MF (nelfilcon A) multifocal contact lenses worn in Period 1, followed by PROCLEAR 1D MF (omafilcon A) multifocal contact lenses worn in Period 2. Both products were worn bilaterally (in both eyes) for 5 ±1 days in a daily wear, daily disposable modality.

Group Type OTHER

DACP MF

Intervention Type DEVICE

Nelfilcon A multifocal contact lenses

PROCLEAR 1D MF

Intervention Type DEVICE

Omafilcon A multifocal contact lenses

PROCLEAR 1D MF, then DACP MF

PROCLEAR 1D MF (omafilcon A) multifocal contact lenses worn in Period 1, followed by DACP MF (nelfilcon A) multifocal contact lenses worn in Period 2. Both products were worn bilaterally (in both eyes) for 5 ±1 days in a daily wear, daily disposable modality.

Group Type OTHER

DACP MF

Intervention Type DEVICE

Nelfilcon A multifocal contact lenses

PROCLEAR 1D MF

Intervention Type DEVICE

Omafilcon A multifocal contact lenses

Interventions

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DACP MF

Nelfilcon A multifocal contact lenses

Intervention Type DEVICE

PROCLEAR 1D MF

Omafilcon A multifocal contact lenses

Intervention Type DEVICE

Other Intervention Names

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DAILIES® AquaComfort Plus® Multifocal (DACP MF) Nelfilcon A PROCLEAR® 1 DAY MULTIFOCAL (PROCLEAR 1D MF) Omafilcon A

Eligibility Criteria

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Inclusion Criteria

* Must sign an informed consent;
* Adapted soft contact lens wearer;
* Vision correctable to 20/30 \[(0.2 logMAR (logarithm of the minimum angle of resolution)\] or better in each eye at distance;
* Willing to wear lenses every day or for at least 5 days per week, 6 hours per day;

Exclusion Criteria

* Currently wearing multifocal contact lenses;
* Currently wearing monovision;
* Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
* Use of systemic or ocular medications which could contraindicate contact lens wear;
* Eye injury or surgery within 12 weeks prior to enrollment;
* Prior refractive surgery;
* Monocular (only 1 eye with functional vision) or fit with only 1 lens;

Minimum Eligible Age

41 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No