CompletedInterventionalNot ApplicableUpdated Jun 29, 2012
Comparison of Three Soft Bifocal Contact Lenses | NCT00808340 | Trialant
CompletedInterventionalNot ApplicableUpdated Jun 19, 2018
Comparison of Three Soft Bifocal Contact Lenses
ClinicalTrials.gov ID
NCT00808340
Lead Sponsor
Johnson & Johnson Vision Care, Inc.INDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Not Applicable
Enrollment
37Actual
Last Update Posted
Jun 19, 2018Actual
Start Date
Nov 1, 2008Actual
Primary Completion Date
Dec 1, 2008Actual
Completion Date
Dec 1, 2008Actual
Brief Summary
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.
Presbyopia
balafilcon A
senofilcon A production
senofilcon A test
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 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.