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| ID | Type | Description | Link |
|---|---|---|---|
| C-12-026 | Other Identifier | Alcon |
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The purpose of this feasibility study was to compare AIR OPTIX® COLORS contact lenses manufactured using an automated process to AIR OPTIX® COLORS contact lenses manufactured using a semi-automatic process.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AIR OPTIX® COLORS Auto, then AIR OPTIX® COLORS Semi-auto | Other | Lotrafilcon B contact lens with color, automated, worn first, with Lotrafilcon B contact lens with color, semi-automated, worn second. Each product worn on a daily wear basis approximately 8 hours a day, 5 days a week, for 2 weeks. |
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| AIR OPTIX® COLORS Semi-auto, then AIR OPTIX® COLORS Auto | Other | Lotrafilcon B contact lens with color, semi-automated, worn first, with Lotrafilcon B contact lens with color, automated, worn second. Each product worn on a daily wear basis approximately 8 hours a day, 5 days a week, for 2 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lotrafilcon B contact lens with color, automated | Device | Silicone hydrogel contact lens with color manufactured via an automated process |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall satisfaction | The participant was asked, "Please rate your overall satisfaction based on your experience with the study lenses over the last 2 weeks. When considering your rating, please take into account comfort, vision, and handling, but disregard the appearance of the lenses." Overall satisfaction was rated on a scale of 1-10, with 1=Not at all satisfied, and 10=Completely satisfied. | Week 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall lens fit | Overall lens fit was assessed by the investigator on a 5-point scale, with +2=Unacceptably loose, +1=Acceptably loose, 0=Optimal, -1=Acceptably tight, -2=Unacceptably tight. | Dispense (Day 0) |
| Overall lens fit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sharon Holden Thomas, O.D. | Alcon Research | Study Director |
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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, semi-automated | Device | Silicone hydrogel contact lens with color manufactured via a semi-automated process |
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Overall lens fit was assessed by the investigator on a 5-point scale, with +2=Unacceptably loose, +1=Acceptably loose, 0=Optimal, -1=Acceptably tight, -2=Unacceptably tight.
| Week 2 |
| Contact Lens Corrected Visual Acuity (CLCVA) | CLCVA (corrected distance monocular visual measurement in normal illumination) was tested for each eye individually while wearing study lenses. Participant read a Snellen chart distant to the participant in normal lighting, with 20/20 Snellen acuity considered normal distance eyesight. | Dispense (Day 0) |
| Corrected distance monocular visual measurement in normal illumination reported as Contact Lens Corrected Visual Acuity (CLCVA) | As tested for each eye individually while wearing study lenses. Participant will read a Snellen chart distant to the participant in normal lighting, with 20/20 Snellen acuity considered normal distance eyesight. | Week 2 |