Myopia
Conditions
Brief summary
The purpose of this study is to compare the performance of two different contact lens care solutions, specifically their affects on the front surface of the eye.
Interventions
DEVICEsoft contact lens
DRUGMarketed multipurpose disinfection regimen
Sponsors
Alcon Research
University of Waterloo
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
1. Is at least 18 years old and has full legal capacity to volunteer. 2. Has read, understood and signed an Information Consent Letter. 3. Is willing and able to follow instructions and maintain the appointment schedule. 4. Is correctable to a visual acuity of 6/6 or better (each eye), with their habitual visual 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 2 years. 8. Has not worn contact lenses before, or has worn contact lenses only for a trial period, with no trials occurring within the last six months. An ineligible contact lens wearer is one who: 9. Responds positively to points 1 to 7 above. 10. Has a distance contact lens prescription between -0.50D and -9.00 D. 11. Has astigmatism less than or equal to -1.00D cyl. 12. Currently wears silicone hydrogel contact lenses successfully. 13. Agrees to wear the study lenses on a daily wear basis without the use of ocular or lens lubricants.
Exclusion criteria
1. Has undergone corneal refractive surgery. 2. Is aphakic. 3. Has any active ocular disease. 4. Has any systemic disease affecting ocular health. 5. Is using any systemic or topical medications that may affect ocular health. 6. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study. 7. Is pregnant or lactating. 8. Is participating in any other type of clinical or research study. An ineligible contact lens wearer is one who: 9. Responds positively to any of points 1 to 8 above for
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure of this study is to investigate the effects of two | — |
| different contact lens care solutions on the cornea. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome measure of this study is to compare the subjective and | — |
| objective responses between two different contact lens care solutions. | — |
Countries
Canada
Outcome results
None listed