Status:
COMPLETED
Clinical Performance Comparison of Several Different Contact Lenses
Lead Sponsor:
Johnson & Johnson Vision Care, Inc.
Conditions:
Myopia
Eligibility:
All Genders
18-39 years
Phase:
NA
Brief Summary
The purpose of the study is to evaluate the possible benefits of second generation silicone hydrogel contact lenses.
Eligibility Criteria
Inclusion
- Subjects must:
- be existing soft contact lens wearers of the study control lenses
- require a distance visual correction in both eyes
- have a contact lens spherical distance requirement between -1.00 diopters (D) and -8.00D in both eyes
- have astigmatism less than or equal to 1.00D in both eyes
- be able to wear lenses available for this study
- be corrected to a visual acuity of 6/9 (20/30) or better in each eye
- have normal eyes with no evidence of abnormality or disease
Exclusion
- Subject are excluded for the following reasons:
- monovision corrected
- worn lenses extended wear in the last 3 months.
- require concurrent ocular medication
- grade 3 or 4 abnormalities
- grade 3 corneal staining in more than two regions
- anterior ocular surgery
- any other ocular surgery or injury within 8 weeks prior to study enrollment
- abnormal lachrymal secretions
- pre-existing ocular irritation that would preclude contact lens fitting
- corneal irregularities
- Polymethyl methacrylate (PMMA) or Rigid Gas Permeable (RGP) lens wear in past 12 weeks
- any systemic illness which would preclude contact lens wear
- diabetes
- infectious or immunosuppressive disease
- pregnancy or lactating, or planning pregnancy at time or enrollment
- participating in a concurrent clinical study or within last 60 days
- allergy to the standardized study care solution
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT00912028
Start Date
May 1 2009
End Date
February 1 2010
Last Update
June 19 2018
Active Locations (11)
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1
Salvador, Estado de Bahia, Brazil, 41810-570
2
Maringá, Paraná, Brazil, 87014-110
3
Recife, Pernambuco, Brazil, 51020-031
4
Rio de Janeiro, Rio de Janeiro, Brazil, 22640-100