Comparison of Two Soft Bifocal Contact Lenses

Completed · Not applicable

Conditions studied: Presbyopia

In brief

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

Key facts

Study ID

NCT00724945

Run by

Johnson & Johnson Vision Care, Inc.

People needed

113

Starts

2008-07-01

Expected to finish

2008-08-01

Last updated by the study team

2015-05-21

Who can join

Age: 35 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Dr. James Weber & Associates — Jacksonville, Florida, United States
• Ted Brink & Associates — Jacksonville, Florida, United States
• Study site — Jacksonville, Florida, United States
• Eye Associates of Winter Park — Winter Park, Florida, United States
• Lee Rigel — East Lansing, Michigan, United States
• Timothy R. Poling, OD — Roanoke, Virginia, United States

Full record on ClinicalTrials.gov

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