Status:
COMPLETED
Clinical Evaluation of the Long-Term Effects of Contact Lens Care Systems
Lead Sponsor:
Johnson & Johnson Vision Care, Inc.
Conditions:
Myopia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to compare two marketed contact lens care solutions in regards to comfort and ocular health.
Eligibility Criteria
Inclusion
- 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
- 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.
- Abnormal lacrimal secretions.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
473 Patients enrolled
Trial Details
Trial ID
NCT00813761
Start Date
September 1 2008
End Date
August 1 2009
Last Update
June 19 2018
Active Locations (26)
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1
North Little Rock, Arkansas, United States
2
Campbell, California, United States
3
Cupertino, California, United States
4
Laguna Niguel, California, United States