Comparison of Two Soft Bifocal Contact Lenses

Johnson & Johnson (J&J)

Status: Completed

Conditions: Presbyopia

Treatments: Device: balafilcon A; Device: senofilcon A

Study type: Interventional

Funder types: Industry

Identifiers

NCT00724945

CR-1485CK

Details and patient eligibility

About

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

Enrollment: 113 patients

Sex: All

Ages: 35 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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113 participants in 2 patient groups

senofilcon A / balafilcon A

Active Comparator group

Description:

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

Treatment:

Device: senofilcon A

Device: balafilcon A

balafilcon A/senofilcon A

Active Comparator group

Description:

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

Treatment:

Device: senofilcon A

Device: balafilcon A