Clinical Evaluation of the Long-Term Effects of Contact Lens Care Systems
NCT ID: NCT00813761
Last Updated: 2018-06-19
Study Results
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View full resultsBasic Information
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COMPLETED
NA
473 participants
INTERVENTIONAL
2008-09-01
2009-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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02Optix CL and ReNu MPS with SICS
O2Optix contact lens and ReNu MultiPlus Multi-Purpose Solution
O2Optix contact lens
control contact lens to be worn daily for approximately 7 months for entire length of study.
ReNu MultiPlus Multi-Purpose Solution
lens solution for overnight lens disinfection
Proclear CL and ReNu MPS with SICS
Proclear contact lens and ReNu MultiPlus Multi-Purpose Solution
Proclear contact lens
control contact lens to be worn for entire length of study.
ReNu MultiPlus Multi-Purpose Solution
lens solution for overnight lens disinfection
02Optix CL and Clear Care LCS with SICS
O2Optix contact lens and Clear Care lens care solution subject
O2Optix contact lens
control contact lens to be worn daily for approximately 7 months for entire length of study.
Clear Care Cleaning and Disinfecting Solution
lens solution for overnight lens disinfection
Proclear CL and Clear Care LCS with SICS
Proclear contact lens and Clear Care lens care solution
Proclear contact lens
control contact lens to be worn for entire length of study.
Clear Care Cleaning and Disinfecting Solution
lens solution for overnight lens disinfection
02Optix CL and ReNu MPS without SICS
O2Optix contact lens and ReNu MultiPlus Multi-Purpose Solution
O2Optix contact lens
control contact lens to be worn daily for approximately 7 months for entire length of study.
ReNu MultiPlus Multi-Purpose Solution
lens solution for overnight lens disinfection
Proclear CL and ReNu MPS without SICS
Proclear contact lens and ReNu MultiPlus Multi-Purpose Solution
Proclear contact lens
control contact lens to be worn for entire length of study.
ReNu MultiPlus Multi-Purpose Solution
lens solution for overnight lens disinfection
02Optix CL and Clear Care LCS without SICS
O2Optix contact lens and Clear Care lens care solution
O2Optix contact lens
control contact lens to be worn daily for approximately 7 months for entire length of study.
Clear Care Cleaning and Disinfecting Solution
lens solution for overnight lens disinfection
Proclear CL and Clear Care LCS without SICS
Proclear contact lens and Clear Care lens care solution
Proclear contact lens
control contact lens to be worn for entire length of study.
Clear Care Cleaning and Disinfecting Solution
lens solution for overnight lens disinfection
Interventions
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O2Optix contact lens
control contact lens to be worn daily for approximately 7 months for entire length of study.
Proclear contact lens
control contact lens to be worn for entire length of study.
ReNu MultiPlus Multi-Purpose Solution
lens solution for overnight lens disinfection
Clear Care Cleaning and Disinfecting Solution
lens solution for overnight lens disinfection
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Johnson & Johnson Vision Care, Inc.
INDUSTRY
Responsible Party
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Locations
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North Little Rock, Arkansas, United States
Campbell, California, United States
Cupertino, California, United States
Laguna Niguel, California, United States
Mission Viejo, California, United States
San Clemente, California, United States
Colorado Springs, Colorado, United States
Bloomington, Illinois, United States
Neodesha, Kansas, United States
Raytown, Missouri, United States
Warrensburg, Missouri, United States
Florence, New Jersey, United States
Chagrin Falls, Ohio, United States
Warren, Ohio, United States
Kittanning, Pennsylvania, United States
Moon Township, Pennsylvania, United States
Nanticoke, Pennsylvania, United States
State College, Pennsylvania, United States
Warwick, Rhode Island, United States
Chamberlain, South Dakota, United States
Bartlett, Tennessee, United States
Salt Lake City, Utah, United States
Burlington, Vermont, United States
Midlothian, Virginia, United States
Virginia Beach, Virginia, United States
Aston Triangle, Birmingham, United Kingdom
Countries
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Other Identifiers
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CR-4522
Identifier Type: -
Identifier Source: org_study_id
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