Comparison of Two Soft Bifocal Contact Lenses | NCT00724945 | Trialant
CompletedInterventionalNot ApplicableUpdated May 21, 2015
Comparison of Two Soft Bifocal Contact Lenses
ClinicalTrials.gov ID
NCT00724945
Lead Sponsor
Johnson & Johnson Vision Care, Inc.INDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Not Applicable
Enrollment
113Actual
Last Update Posted
May 21, 2015Estimated
Start Date
Jul 2008
Primary Completion Date
Aug 2008Actual
Completion Date
Aug 2008Actual
Brief Summary
The purpose of the study is to compare the visual performance of two soft bifocal contact lenses.
Presbyopia
balafilcon A
senofilcon A
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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