Multipurpose Disinfecting Solution Compatibility With a Silicone Hydrogel Contact Lens
Information source: University of Waterloo
Information obtained from ClinicalTrials.gov on October 22, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Myopia; Hyperopia
Intervention: Silicone Hydrogel Contact Lens (Device)
Phase: Phase 3
Status: Recruiting
Sponsored by: University of Waterloo Official(s) and/or principal investigator(s):
Desmond Fonn, M Optom, Principal Investigator, Affiliation: University of Waterloo
Craig Woods, PhD, Principal Investigator, Affiliation: University of Waterloo
Overall contact:
Craig Woods, PhD, Phone: 1 519 888 4567, Ext: 36547, Email: cawoods@uwaterloo.ca
Summary
The purpose of this study is to verify the compatibility of a silicone hydrogel lens when used with four multipurpose disinfecting solutions (OPTI-FREE® RepleniSH®, ReNu MultiPlus®, Solo-Care Aqua™ and MeniCareTM Soft).
Clinical Details
Official title:
Multipurpose Solution Compatibility With a Silicone Hydrogel Lens
Study design: Interventional, Treatment, Randomized, Single Blind (Investigator), Active Control, Crossover Assignment
Primary outcome: To see if there are any effects on the cornea when using each contact lens/solution combination.
Secondary outcome: To quantify comfort and vision ratings with each lens/solution combination.
Eligibility
Minimum age: 17 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
A person is eligible for inclusion in the study if he/she:
1. Is at least 17 years old and has full legal capacity to volunteer
2. Has read and signed an information consent letter, after having the opportunity to ask questions and receive acceptable answers
3. Is willing and able to follow instructions and maintain the study appointment schedule
4. Is correctable to a visual acuity of 6/7. 5 (20/25) or better (both eyes) with their habitual vision correction
5. Has normal binocular vision (no strabismus, no amblyopia, and anisometropia less than or equal to 1. 00 D)
6. Has clear corneas and no active ocular disease
7. Has had an ocular examination in the last two years.
8. Has a functional pair of spectacles
9. Is a current soft lens wearer replacing their lenses at least monthly
10. Has a distance contact lens prescription between +6. 00D to - 10. 00 DS and can be successfully fitted with the study lens
11. Has astigmatism less than or equal to - 1. 00DC
12. Agrees to wear the study lenses on a daily wear basis
Exclusion Criteria:
A person will be excluded from the study if he/she:
1. Has any signs or symptoms of dry eye
2. Has any clinically significant blepharitis
3. Has undergone corneal refractive surgery
4. Is aphakic
5. Has any systemic disease affecting ocular health
6. Is using any systemic or topical medications that may affect ocular health
7. Is pregnant or lactating
8. Is participating in any other type of clinical or research study
9. Currently wears daily disposable lenses
10. Currently wears lenses on a continuous or extended wear basis
11. Is unable to successfully wear contact lenses without routinely using rewetting drops
Locations and Contacts
Craig Woods, PhD, Phone: 1 519 888 4567, Ext: 36547, Email: cawoods@uwaterloo.ca
Centre for Contact Lens Research, University of Waterloo, Waterloo, Ontario N2L 3G1, Canada; Recruiting
Craig Woods, PhD, Phone: 1 519 888 4567, Ext: 36547, Email: cawoods@uwaterloo.ca
Luigina Sorbara, OD, MSc, Principal Investigator
Additional Information
Starting date:
August 2007
Ending date: December 2007
Last updated: August 22, 2007
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