Evaluation of the Performance of AIR OPTIX® COLORS

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Conditions
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Myopia

Intervention / Treatment
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* Device: Lotrafilcon B contact lens
* Device: Lotrafilcon B contact lens with color
* Device: Phemfilcon A contact lens with color


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: AIR OPTIX® AQUA<br>Lotrafilcon B contact lenses worn in both eyes on a daily wear basis for one week in Phase 1. | Device: Lotrafilcon B contact lens<br>* Silicone hydrogel contact lens<br>* Other names: AIR OPTIX® AQUA;|
| Experimental: AIR OPTIX® COLORS<br>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. | Device: Lotrafilcon B contact lens with color<br>* Silicone hydrogel contact lens with color<br>* Other names: AIR OPTIX® COLORS;|
| Active Comparator: FRESHLOOK® COLORBLENDS<br>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. | Device: Phemfilcon A contact lens with color<br>* Hydrogel contact lens with color<br>* Other names: FRESHLOOK® COLORBLENDS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |