Myopia
Conditions
Brief summary
The purpose of this study was to assess the ocular response to and performance of the cosmetically printed silicone hydrogel contact lens AIR OPTIX® COLORS compared to FRESHLOOK® COLORBLENDS.
Detailed description
The study was conducted in two phases. Phase 1 was an adaptation phase where participants wore AIR OPTIX® AQUA contact lenses bilaterally (same product in both eyes) on a daily wear basis for 1 week. In Phase 2, participants wore AIR OPTIX® COLORS and FRESHLOOK® COLORBLENDS contact lenses contralaterally (different product in each eye) on a daily wear basis for 4 weeks.
Interventions
Silicone hydrogel contact lens
Silicone hydrogel contact lens with color
Hydrogel contact lens with color
Sponsors
University of Waterloo
CIBA VISION
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Full legal capacity to volunteer; * Read and sign information and consent letter; * Willing and able to follow instructions and maintain the appointment schedule; * Ocular examination in the last two years; * Currently wears soft contact lenses on a daily wear basis; * Contact lens prescription between -1.50 diopters and -5.00 diopters; * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Any ocular disease; * Any systemic condition that may affect a study outcome variable; * Any systemic or topical medications that may affect ocular health; * Known sensitivity to the diagnostic pharmaceuticals used in the study; * Unable to achieve an acceptable fit with the study lenses; * Anisometropia \>1.00 diopter or astigmatism \>0.75 diopter; * Use of lubricating/rewetting eye drops. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual Acuity | Phase 2: Up to Week 4 |
| Corneal Staining | Phase 2: Up to Week 4 |
| Conjunctival Staining | Phase 2: Up to Week 4 |
| Surface Regularity Index (SRI) | Up to Phase 2, Week 4 |
| Surface Asymmetry Index (SAI) | Up to Phase 2, Week 4 |
| Subjective ratings | Phase 2: Up to Week 4 |
Countries
Canada
Outcome results
None listed