Status:
COMPLETED
Clinical Performance Comparison of Two Contact Lenses
Lead Sponsor:
Johnson & Johnson Vision Care, Inc.
Collaborating Sponsors:
Visioncare Research Ltd.
Conditions:
Myopia
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief Summary
The purpose of this study is to compare the clinical performance of two contact lenses.
Eligibility Criteria
Inclusion
- Existing daily soft lens wearer.
- Require a distance visual correction in both eyes.
- Have a contact lens spherical distance refraction between -1.00D and -6.00D.
- Have refractive astigmatism less than or equal to 1.00D in both eyes.
- Achieve 20/30 or better corrected distance acuity.
- Have normal eyes with no evidence of abnormality or disease.
Exclusion
- Requires presbyopic correction.
- Requires ocular medications.
- Grade 3 or 4 ocular abnormalities.
- Grade 3 corneal staining in more than one region.
- Has had refractive surgery.
- Any other injury or ocular surgery within 8 weeks prior to study enrollment.
- Has abnormal lacrimal secretions.
- Pre-existing ocular irritation that would preclude contact lens fitting.
- Has keratoconus or other corneal irregularity.
- Polymethyl methacrylate (PMMA), Hybrid or Rigid Gas Permeable (RGP) wear in the previous 8 weeks.
- Wears habitual contact lenses that are toric, multifocal or worn extended wear.
- Any systemic illness which would contraindicate lens wear or the medical treatment of would affect vision or successful lens wear.
- Diabetic.
- Infectious or immunosuppressive disease.
- History of chronic eye disease (e.g glaucoma or age related macular degeneration).
- Pregnancy, lactation or planning pregnancy at time of enrollment.
- Participation in any concurrent clinical trial or in another trial in the last 30 days.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
379 Patients enrolled
Trial Details
Trial ID
NCT00975585
Start Date
August 1 2009
End Date
October 1 2009
Last Update
June 19 2018
Active Locations (25)
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1
North Little Rock, Arkansas, United States, 72116
2
Campbell, California, United States, 95008
3
Colorado Springs, Colorado, United States, 80909
4
Jacksonville, Florida, United States, 32205