Status:
COMPLETED
Corneal and Conjunctival Sensitivity and Staining Study
Lead Sponsor:
University of Waterloo
Collaborating Sponsors:
Alcon Research
Conditions:
Myopia
Hyperopia
Eligibility:
All Genders
17-45 years
Phase:
PHASE4
Brief Summary
The primary objective of this study is to compare subjective symptoms and ocular health in a group of individuals who are currently wearing soft contact lenses on a daily wear basis, after a short per...
Detailed Description
The primary objective of this study is to compare subjective symptoms and ocular health in a group of individuals who are currently wearing soft contact lenses on a daily wear basis, after a short per...
Eligibility Criteria
Inclusion
- An eligible participant is one who:
- Is between 17-45 years old and has full legal capacity to volunteer.
- Has read and signed an information consent letter, after having the opportunity to ask questions and receive acceptable answers.
- Is willing and able to follow instructions and maintain the appointment schedule.
- Does not experience any dryness related symptoms during lens wear (i.e. at least 12 hours of comfortable wearing time)
- Is correctable to a visual acuity of 6/7.5 (20/25) or better (each eye) with their habitual vision correction.
- Has normal binocular vision (no strabismus, no amblyopia).
- Has clear corneas and no active ocular disease.
- Has had an ocular examination in the last two years. Has a distance contact lens prescription between +0.50D to +6.00 DS and -0.50D and -12.00 DS.
- Has astigmatism less than or equal to -1.00DC.
- Agrees to wear the study lenses on a daily wear basis.
- Has a pair of glasses with updated prescription and agrees to wear them during the period no lens wear (7-10 days) as required by the study.
Exclusion
- A person is ineligible if he/she:
- Has undergone corneal refractive surgery.
- Is aphakic.
- Has any active ocular disease.
- Has any systemic disease affecting ocular health.
- Is using any systemic or topical medications that may affect ocular health.
- Has a known sensitivity to the diagnostic pharmaceuticals to be used in the study.
- Is pregnant or lactating.
- Is participating in any other clinical or research study.
- Has a known clinically significant sensitivity to the contact lens care solutions used in the study.
- Has ocular or systemic allergies that could adversely affect contact lens wear.
- Currently wears lenses on a continuous or extended wear basis.
- Has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that would affect the wearing of contact lenses.
- Has pinguecula/pterygium that, in the investigator's judgment, makes contact lens wear inadvisable.
- Is a rigid lens wearer.
- Has corneal staining graded as 2 (macropunctate) or greater in any corneal region in either eye, sum of corneal staining type (severity) of greater than or equal to 4 across the entire cornea in either eye, or any corneal staining covering greater than or equal to 20% in any corneal region in either eye.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00455455
Start Date
March 1 2007
End Date
December 1 2008
Last Update
July 12 2010
Active Locations (1)
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1
Centre for Contact Lens Research, School of Optometry
Waterloo, Ontario, Canada, N2L 3G1