Comparison of Three Soft Bifocal Contact Lenses

Johnson & Johnson (J&J)

Status: Completed

Conditions: Presbyopia

Treatments: Device: senofilcon A test; Device: balafilcon A; Device: senofilcon A production

Study type: Interventional

Funder types: Industry

Identifiers

NCT00808340

CR-1485FA

Details and patient eligibility

About

The primary purpose of the study is to compare the performance of three soft bifocal contact lenses in terms of the vision provided by the lenses.

Enrollment: 37 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 respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire" or be already wearing presbyopic contact lens correction ( e.g. reading spectacles over contact lenses, multifocal or monovision contact lenses etc.).
• The subject's spherical equivalent distance refraction must be in the range of -1.00 to -6.00 in each eye.
• Refractive cylinder must be less than or equal to -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 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 a contagious 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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37 participants in 6 patient groups

senofilA test/senofilA prod/balafilconA

Active Comparator group

Description:

Subjects wear 3 multifocal contact lenses: senofilcon A test worn first, senofilcon A production worn second, and balafilcon A worn third.

Treatment:

Device: balafilcon A

Device: senofilcon A production

Device: senofilcon A test

senofilcon A test/balafilcon A/senofilcon A prod

Active Comparator group

Description:

Subjects wear 3 multifocal contact lenses: senofilcon A test worn first, balafilcon A worn second, and senofilcon A production worn third.

Treatment:

Device: balafilcon A

Device: senofilcon A production

Device: senofilcon A test

senofilcon A prod/senofilcon A test/balafilcon A

Active Comparator group

Description:

Subjects wear 3 multifocal contact lenses: senofilcon A production worn first, senofilcon A test worn second, and balafilcon A worn third.

Treatment:

Device: balafilcon A

Device: senofilcon A production

Device: senofilcon A test

senofilcon A prod/ balifilcon A/ senofilcon A test

Active Comparator group

Description:

Subjects wear 3 multifocal contact lenses: senofilcon A production worn first, balafilcon A worn second, and senofilcon A test worn third.

Treatment:

Device: balafilcon A

Device: senofilcon A production

Device: senofilcon A test

balafilcon A/senofilcon A test/senofilcon A prod

Active Comparator group

Description:

Subjects wear 3 multifocal contact lenses: balafilcon A worn first, senofilcon A test worn second, and senofilcon A production worn third.

Treatment:

Device: balafilcon A

Device: senofilcon A production

Device: senofilcon A test

balafilcon A/senofilcon A prod/senofilcon A test

Active Comparator group

Description:

Subjects wear 3 multifocal contact lenses: balafilcon A worn first, senofilcon A production worn second, senofilcon A test worn third.

Treatment:

Device: balafilcon A

Device: senofilcon A production

Device: senofilcon A test