Status:
COMPLETED
Dispensing Overnight Study in Lenses
Lead Sponsor:
University of Waterloo
Collaborating Sponsors:
Cooper Companies
Conditions:
Myopia
Eligibility:
All Genders
18-45 years
Phase:
PHASE3
Brief Summary
The purpose of the study is to evaluate the fit and performance of an investigational soft contact lens in comparison with a currently marketed lens. Both lenses will be worn on a continuous wear basi...
Detailed Description
The purpose of the study is to evaluate the fit and performance of an investigational soft contact lens in comparison with a currently marketed lens. Both lenses will be worn on a continuous wear basi...
Eligibility Criteria
Inclusion
- Has had an oculo-visual examination in the last 2 years.
- Is between 18-45 years old and has full legal capacity to volunteer.
- Has read and understood the Information Consent Letter
- Is willing and able to follow participant instructions for product usage and meet the protocol-specified schedule of follow-up visits.
- Is correctable with the prescription of the available lenses (-1.00 to -4.00 DS in 0.50D step).
- Is correctable to at least 20/40 distance visual acuity with contact lenses in each eye.
- Is a current soft contact lens wearer (both daily wear and extended wear experience allowed).
- Has refractive astigmatism of \<= 1.00 diopters
- Has clear corneas and ocular clinical findings considered to be "normal".
Exclusion
- Has any systemic disease affecting ocular health.
- Is using any systemic or topical medications that will affect ocular health.
- Has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that would affect the wearing of contact lenses.
- Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities.
- Has limbal injection, bulbar injection or corneal staining that, in the Investigator's opinion, is clinically significant.
- Has never worn contact lenses before.
- Has corneal distortion resulting from rigid lens wear.
- Is aphakic.
- Has undergone corneal refractive surgery.
- Is participating in any other type of clinical or research study.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00349856
Start Date
January 1 2005
End Date
March 1 2008
Last Update
February 18 2009
Active Locations (1)
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1
Centre for Contact Lens Research, University of Waterloo
Waterloo, Ontario, Canada, N2L3G1