CompletedInterventionalNot ApplicableUpdated Jun 29, 2012
Evaluation of the Performance of Investigational Contact Lenses in a Presbyopic Population | NCT01763047 | Trialant
CompletedInterventionalNot ApplicableUpdated Jun 19, 2018
Evaluation of the Performance of Investigational Contact Lenses in a Presbyopic Population
ClinicalTrials.gov ID
NCT01763047
Lead Sponsor
Johnson & Johnson Vision Care, Inc.INDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Not Applicable
Enrollment
298Actual
Last Update Posted
Jun 19, 2018Actual
Start Date
Nov 2012
Primary Completion Date
Feb 2013Actual
Completion Date
Feb 2013Actual
Brief Summary
The objective of this study is to evaluate the performance of a novel multifocal lens system.
Presbyopia
etafilcon A
lotrafilcon B
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
Yes
Eligibility Criteria
Inclusion Criteria:
Subjects must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
Subjects must appear able and willing to adhere to the instructions set forth in the clinical protocol.
Subjects must be between 40 and 70 years of age.
Subjects' spherical equivalent distance refraction must be in the range of -3.75 to +3.75 in each eye.
Subjects' refractive cylinder must be less than or equal to 0.75D in each eye.
Subjects' ADD power must be in the range of +0.75 to +2.50D in each eye.
Subjects' must have the best corrected visual acuity of 20/20-3 or better in each eye.
Subjects' should own a wearable pair of spectacles.
Subjects' must be an adapted soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 8 hours per wear day, for 1 month or more duration).
Subjects' must respond positively to at least on symptom on the "Presbyopis Symptoms Questionnaire" or already be wearing a presbyopic contact lens correction (e.g. reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.).
Exclusion Criteria:
Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
Any previous intraocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.)
Any grade 3 or greater slit lamp findings (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) which may contraindicate contact lens wear.
Any ocular infection.
Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
History of binocular vision abnormality or strabismus.
Any infectious disease (e.g. hepatitis, tuberculosis) or contagious immunosuppressive disease (e.g. HIV).
History of diabetes.
Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.