Clinical Evaluation of a Multifocal Contact Lens on Symptomatic Patients

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-01

Study Completion Date

2009-12-01

Brief Summary

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The purpose of this study is to evaluate the effect of a multi-focal contact lens on symptomatic patients.

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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 Investigators

Study Groups

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etafilcon A multifocal / etafilcon A sphere

period 1: etafilcon A multifocal worn, period 2: etafilcon A sphere worn.

Group Type OTHER

etafilcon A multifocal contact lens

Intervention Type DEVICE

low-add multifocal contact lens

etafilcon A Contact Lens

Intervention Type DEVICE

standard sphere contact lens

etafilcon A sphere / etafilcon A multifocal

period 1: etafilcon A sphere worn, period 2: etafilcon A multifocal worn.

Group Type OTHER

etafilcon A multifocal contact lens

Intervention Type DEVICE

low-add multifocal contact lens

etafilcon A Contact Lens

Intervention Type DEVICE

standard sphere contact lens

Interventions

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etafilcon A multifocal contact lens

low-add multifocal contact lens

Intervention Type DEVICE

etafilcon A Contact Lens

standard sphere contact lens

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* To have signed an informed consent form (documented by the investigator in the Case Report Form \[CRF\]).
* Be existing daily wear spherical single-vision soft CL wearers (no extended wear in the last 3 months, but silicone hydrogels in daily wear are allowed).
* Between 35 and 47 years of age (inclusive).
* Have a CL spherical distance requirement between -1.00D and -6.00D (-6.50D refractive) in both eyes.
* Refractive astigmatism of 0.75D or less in both eyes.
* Visual symptoms associated with near vision
* Be correctable to a visual acuity of 6/9 (20/30) or better in each eye.
* Have normal eyes with no evidence of abnormality or disease. For the purpose of this study a normal eye is defined as one having:

1. No amblyopia.
2. No evidence of lid abnormality or infection.
3. No conjunctival abnormality or infection.
4. No clinically significant slit lamp findings (i.e. stromal haze, staining, scarring, Vascularization, infiltrates or abnormal opacities).
5. No other active ocular disease.

Exclusion Criteria

* Monovision user or multifocal CL wearer.
* Regular user of reading spectacles (i.e. daily usage).
* Requires concurrent ocular medication.
* Clinically significant (Grade 3 or 4) corneal stromal haze, corneal Vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate CL wear.
* Corneal staining Grade 3 in more than two regions.
* Has had any anterior ocular surgery. Has had any other ocular surgery or injury within 8 weeks immediately prior to enrollment for this study.
* Pre-existing ocular irritation that would preclude CL fitting.
* Keratoconus or other corneal irregularity.

Minimum Eligible Age

35 Years

Maximum Eligible Age

47 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No