Hyperopia, Myopia
Conditions
Brief 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).
Detailed description
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) by observing changes within the cornea.
Interventions
use of lens over 2 days
Sponsors
Menicon Co., Ltd.
University of Waterloo
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
17 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To see if there are any effects on the cornea when using each contact lens/solution combination. | Over 2 days |
Secondary
| Measure | Time frame |
|---|---|
| To quantify comfort and vision ratings with each lens/solution combination. | over 2 days |
Countries
Canada
Outcome results
None listed