A Comparison of Two Color Contact Lenses in Habitual Clear Contact Lens Wearers

Study Overview
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Brief Summary
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The purpose of this study was to evaluate overall satisfaction with AIR OPTIX® COLORS as compared to FRESHLOOK® COLORBLENDS contact lenses.

Official Title
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A Comparison of Two Color Contact Lenses in Habitual Clear Contact Lens Wearers

Conditions
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Myopia, Refractive Error

Intervention / Treatment
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* 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: Willing and able to sign Informed Consent Document. If under legal age of consent, legally authorized representative must also sign Informed Consent Document. Able to achieve best corrected visual acuity (BCVA) of 20/25 (Snellen) or better in each eye at distance. Manifest cylinder less than or equal to 0.75 diopter in each eye. Wear contact lenses within protocol-defined specifications. Require spherical contact lenses within the available range of powers. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Any eye condition that contraindicates contact lens wear. Any systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of their accessory solutions. Moderate or severe ocular findings upon examination. Any use of systemic or ocular medications that could contraindicate contact lens wear, including use of topical ocular medications requiring instillation during contact lens wear, except for approved lubricating drops. Habitual lenses worn in an extended wear modality (routinely sleeping in lenses overnight for 1 night per week or more) over the last 3 months prior to enrollment. Previous corneal or refractive surgery or irregular cornea. Eye injury or surgery within the last 6 months (excluding placement of punctal plugs). Monovision and monocular subjects (only one eye with functional vision) or subjects fit with only one lens. History of intolerance or hypersensitivity to any component of the test articles. Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 16 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AIR OPTIX® COLORS<br>Lotrafilcon B contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day. | 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 worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day. | 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 |
| --- | --- | --- |
| Subjective Rating of Overall Satisfaction | Overall satisfaction, as rated by the participant on a 10-point scale, with 1 being very dissatisfied to 10 being very satisfied. The participant rated both eyes together by providing one single rating. | Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive Purchase Intent | As reported on a questionnaire in response to, Assuming these lenses were at a price you would expect to pay, how likely would you be to purchase these lenses? The binary 'positive' vs 'negative' response variable was derived from a 5-point Likert scale. Positive purchase intent is reported as the percentage of participants choosing Definitely would purchase or Probably would purchase. | Day 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Color contact lenses, Refractive error, Myopia