Evaluation of the Performance of AIR OPTIX® COLORS

Ciba Vision

Status: Completed

Conditions: Myopia

Treatments: Device: Phemfilcon A contact lens with color; Device: Lotrafilcon B contact lens with color; Device: Lotrafilcon B contact lens

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01338402

P/363/10/C (Other Identifier)

P-368-C-108

Details and patient eligibility

About

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.

Full 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.

Enrollment: 47 patients

Sex: All

Ages: 17+ years old

Volunteers: No Healthy Volunteers

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 exclusion criteria may apply.

Trial design

47 participants in 3 patient groups

AIR OPTIX® AQUA

Other group

Description:

Lotrafilcon B contact lenses worn in both eyes on a daily wear basis for one week in Phase 1.

Treatment:

Device: Lotrafilcon B contact lens

AIR OPTIX® COLORS

Experimental group

Description:

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.

Treatment:

Device: Lotrafilcon B contact lens with color

FRESHLOOK® COLORBLENDS

Active Comparator group

Description:

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.

Treatment:

Device: Phemfilcon A contact lens with color