Comparison of Two Soft Bifocal Contact Lenses

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2008-08-31

Brief Summary

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The purpose of the study is to compare the visual performance of two soft bifocal contact lenses.

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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

SINGLE

Participants

Study Groups

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senofilcon A / balafilcon A

senofilcon A multifocal lenses worn first, balafilcon A multifocal lenses worn second

Group Type ACTIVE_COMPARATOR

balafilcon A

Intervention Type DEVICE

multifocal contact lens

senofilcon A

Intervention Type DEVICE

multifocal contact lens

balafilcon A/senofilcon A

balafilcon A multifocal lenses worn first, senofilcon A multifocal lenses worn second

Group Type ACTIVE_COMPARATOR

balafilcon A

Intervention Type DEVICE

multifocal contact lens

senofilcon A

Intervention Type DEVICE

multifocal contact lens

Interventions

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balafilcon A

multifocal contact lens

Intervention Type DEVICE

senofilcon A

multifocal contact lens

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* The subject must between 35 and 70 years of age.
* The subject must have presbyopic symptoms or be already wearing presbyopic contact lens correction.
* The subject's spherical equivalent distance refraction must be in the range of -1.00 to -6.00 or -9.00 to -10.00 in each eye.
* Refractive cylinder must be -0.75 D in each eye.
* The subject must have an ADD power of +0.75D to +2.50D in each eye.
* The subject must have best corrected visual acuity of 20/20-3 or better in each eye
* The subject's must have at least 20/30-distance vision OU with the study contact lenses.
* The subject must agree that they are comfortable with their vision prior to being dispensed the study lenses
* The subject must be an adapted soft contact lens wearer in both eyes.
* The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
* The subject must read and sign the STATEMENT OF INFORMED CONSENT and be provided a copy of the form.

Exclusion Criteria

* Ocular or systemic allergies or disease that may interfere with contact lens wear.
* Systemic disease, autoimmune disease or use of medication, which may interfere with contact lens wear.
* Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining or any other abnormality of the cornea, which may contraindicate contact lens wear
* Clinically significant (grade 3 or 4) tarsal abnormalities that might interfere with contact lens wear.
* Any ocular infection.
* Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
* Pregnancy or lactation
* Any infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
* History of diabetes
* History of binocular vision abnormality or strabismus

Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No