Clinical Evaluation of the Long-Term Effects of Contact Lens Care Systems | NCT00813761 | Trialant
CompletedInterventionalNot ApplicableUpdated Jun 19, 2018
Clinical Evaluation of the Long-Term Effects of Contact Lens Care Systems
ClinicalTrials.gov ID
NCT00813761
Lead Sponsor
Johnson & Johnson Vision Care, Inc.INDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Not Applicable
Enrollment
473Actual
Last Update Posted
Jun 19, 2018Actual
Start Date
Sep 1, 2008Actual
Primary Completion Date
Aug 1, 2009Actual
Completion Date
Aug 1, 2009Actual
Brief Summary
The purpose of this study is to compare two marketed contact lens care solutions in regards to comfort and ocular health.
Myopia
O2Optix contact lens
Proclear contact lens
ReNu MultiPlus Multi-Purpose Solution
Clear Care Cleaning and Disinfecting Solution
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Be at least 18 years old.
Signed Informed Consent and Investigator to record this on Case Report Form (CRF) in appropriate space.
Require a visual correction in both eyes (monovision allowed but not monofit).
Have a contact lens spherical distance requirement between +6.00D and -9.00D in both eyes.
Astigmatism of 1.00D or less in the better eye and 1.50D or less in the other eye.
Be correctable to a visual acuity of 20/30 (6/9) or better in each eye.
Have normal eyes with no evidence of abnormality or disease.
Exclusion Criteria:
Requires concurrent ocular medication.
Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
Clinically significant corneal edema, corneal vascularisation, tarsal abnormalities, bulbar injection or any other abnormality of the cornea that would contraindicate contact lens wear.
Worn lenses on an extended wear basis in the last 3 months.
Diabetic.
Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
Polymethyl methacrylate (PMMA) or rigid gas-permeable (RGP) lens wear in the previous 8 weeks.
Has had refractive surgery. Has had eye injury/surgery within 8 weeks immediately prior to enrolment for this study.