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| ID | Type | Description | Link |
|---|---|---|---|
| P/363/10/C | Other Identifier | University of Waterloo |
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| Name | Class |
|---|---|
| University of Waterloo | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AIR OPTIX® AQUA | Other | Lotrafilcon B contact lenses worn in both eyes on a daily wear basis for one week in Phase 1. |
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| AIR OPTIX® COLORS | Experimental | Lotrafilcon B contact lens with color randomly assigned to one eye, with phemfilcon A contact lens with color in the fellow eye for contralateral wear. Both products worn on a daily wear basis for 4 weeks in Phase 2. A replacement phemfilcon A lens was dispensed at the Week 2 visit. |
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| FRESHLOOK® COLORBLENDS | Active Comparator | Phemfilcon A contact lens with color randomly assigned to one eye, with lotrafilcon B contact lens with color in the fellow eye for contralateral wear. Both products worn on a daily wear basis for 4 weeks in Phase 2. A replacement phemfilcon A lens was dispensed at the Week 2 visit. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lotrafilcon B contact lens | Device | Silicone hydrogel contact lens |
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| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Desmond Fonn, MOptom, FAAO | University of Waterloo Centre for Contact Lens Research | Principal Investigator |
| Lyndon Jones, PhD, FCOptom, FAAO | University of Waterloo Centre for Contact Lens Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Contact Lens Research, University of Waterloo | Waterloo | Ontario | N2L 3G1 | Canada |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Lotrafilcon B contact lens with color | Device | Silicone hydrogel contact lens with color |
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| Phemfilcon A contact lens with color | Device | Hydrogel contact lens with color |
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