Not provided
Not provided
Not provided
Not provided
Not provided
Information to be gathered in survey format instead of a clinical investigation.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to gather long-term performance and safety data on AIR OPTIXâ„¢ COLORS (lotrafilcon B) plano cosmetic contact lenses in subjects 12 years of age and older. AIR OPTIXâ„¢ COLORS plano contact lenses do not contain visual correction and are worn for cosmetic purposes only.
Eligible participants will receive the contact lens color of their choice (if available) to be used as intended by the manufacturer for the duration of their participation in the study, approximately 1 year.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AIR OPTIX COLORS | Experimental | Lotrafilcon B plano cosmetic contact lenses worn in both eyes at least 5 hours per day, at least 2 days a week, for one year. Lenses will be replaced monthly and cleaned, rinsed, disinfected, and stored in accordance with the package labeling of the lens care products recommended by the eye care professional. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lotrafilcon B plano cosmetic contact lenses | Device | Commercially approved colored contact lenses worn for cosmetic purposes to alter or enhance the apparent color of the eye |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of corneal infiltrative events | A corneal infiltrate is a single or group of inflammatory cells in the normally clear cornea. | Up to Year 1 |
| Incidence of microbial keratitis | Microbial keratitis is a sight-threatening infection of the cornea. | Up to Year 1 |
Not provided
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Lead, Vision Care | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact Alcon Call Center for Trial Locations | Fort Worth | Texas | 76134 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided