In-vivo Wettability Grading and Assessment Study

Study Overview
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Brief Summary
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The purpose of this study is to investigate the front surface wettability of soft contact lenses while on eye.

Conditions
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Myopia

Intervention / Treatment
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* Device: lotrafilcon B
* Device: balafilcon A
* Device: senofilcon A
* Device: enfilcon A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: is at least 17 years of age has read and signed an information consent letter is a current daily wear contact lens wearer has acceptable fit with the study lenses has had an ocular exam in the last two years other protocol-defined inclusion criteria may apply Exclusion Criteria: has any ocular disease has undergone corneal refractive surgery or is aphakic has any systemic disease affecting ocular health is pregnant or lactating 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

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: lotrafilcon B<br>Lotrafilcon B contact lens randomly assigned to one eye, with balafilcon A contact lens assigned to the fellow eye for contralateral wear. Both products to be worn on a daily wear basis for 4 weeks, after which participant will wear senofilcon A contact lens randomly assigned to one eye and enfilcon A contact lens in the fellow eye for an additional 4 weeks of daily wear. | Device: lotrafilcon B<br>* Commercially marketed, silicone hydrogel, spherical contact lens<br>* Other names: Air Optix;|
| Active Comparator: balafilcon A<br>Balafilcon A contact lens randomly assigned to one eye, with lotrafilcon B contact lens assigned to the fellow eye for contralateral wear. Both products to be worn on a daily wear basis for 4 weeks, after which participant will wear senofilcon A contact lens randomly assigned to one eye and enfilcon A contact lens in the fellow eye for an additional 4 weeks of daily wear. | Device: balafilcon A<br>* Commercially marketed, silicone hydrogel, spherical contact lens<br>* Other names: PureVision;|
| Active Comparator: senofilcon A<br>Senofilcon A contact lens randomly assigned to one eye, with enfilcon A contact lens assigned to the fellow eye for contralateral wear. Both products to be worn on a daily wear basis for 4 weeks, after which participant will wear lotrafilcon B contact lens randomly assigned to one eye and balafilcon A contact lens in the fellow eye for an additional 4 weeks of daily wear. | Device: senofilcon A<br>* Commercially marketed, silicone hydrogel, spherical contact lens<br>* Other names: Acuvue OASYS;|
| Active Comparator: enfilcon A<br>Enfilcon A contact lens randomly assigned to one eye, with senofilcon A contact lens assigned to the fellow eye for contralateral wear. Both products to be worn on a daily wear basis for 4 weeks, after which participant will wear lotrafilcon B contact lens randomly assigned to one eye and balafilcon A contact lens in the fellow eye for an additional 4 weeks of daily wear. | Device: enfilcon A<br>* Commercially marketed, silicone hydrogel, spherical contact lens<br>* Other names: Avaira;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| On-eye Wettability | On-eye wettability, as assessed at the 4-week visit by a masked observer from a video taken of the eye 5 minutes after lens insertion. On-eye wettability was recorded on a 5-point scale, with 0=excellent and 4=very poor. | 4 weeks of wear |