DW Evaluation of Lotrafilcon B Lenses in a Modified Design

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate that Lotrafilcon B AIR OPTIX® AQUA sphere modified design lenses are noninferior to Lotrafilcon B AIR OPTIX® AQUA in overall lens fit by comparing the percent of subjects satisfying the no re-fit criteria in each treatment group.

Official Title
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Daily Wear (DW) Evaluation of Lotrafilcon B in a Modified Design

Conditions
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Myopia

Intervention / Treatment
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* Device: Lotrafilcon B sphere modified design contact lenses
* Device: Lotrafilcon B sphere contact lenses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must sign an Informed Consent Document; Myopic, wear AIR OPTIX® AQUA lenses in the range of -1.00 to -5.00 diopters (D) in both eyes, and willing to comply with the wearing schedule; Manifest cylinder less than or equal to 0.75 D; Able to achieve best corrected visual acuity (BCVA) of 20/25 (Snellen) or better in each eye at distance; Able to achieve distance visual acuity of at least 20/40 in each eye with habitual and study lenses; Wearing spherical AIR OPTIX® AQUA lenses in both eyes for at least 3 months (at least 8 hours per day, at least 5 days per week), wearing the habitual lenses for a minimum of 4 hours prior to the baseline study visit, and achieving an acceptable or optimal fit at baseline visit with habitual lenses in both eyes; Other protocol-defined criteria may apply. Exclusion Criteria: Current soft contact lens wearer who regularly sleeps in lenses (1 or more nights per week); Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear within 6 months prior to enrollment; Any use of systemic or ocular medications for which contact lens wear could be contraindicated including any use of topical ocular medications that would require instillation during contact lens wear; History of herpetic keratitis; History of corneal or refractive surgery or irregular cornea; A pathologically dry eye that precludes contact lens wear; Monocular (only one eye with functional vision); Monovision correction; History of intolerance or hypersensitivity to any component of the test articles or associated materials; Concurrent participation in a contact lens or contact lens care product clinical trial or within the previous 30 days; Eye injury or ocular or intra-ocular surgery within 6 months prior to enrollment; Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the study lenses or affect the results of this study; Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AOA Modified<br>Lotrafilcon B sphere modified design contact lenses worn at least 8 hours per day, 5 days per week on a daily wear basis for 7 days. | Device: Lotrafilcon B sphere modified design contact lenses<br> <br> |
| Active Comparator: AOA<br>Lotrafilcon B sphere contact lenses worn at least 8 hours per day, 5 days per week on a daily wear basis for 7 days. | Device: Lotrafilcon B sphere contact lenses<br> <br> * Other names: AOA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subjects Satisfying the 'no Re-fit' Criteria in Both Eyes | With the contact lens on eye, the investigator assessed the lens fit immediately post-blink and following lower lid margin push-up with the lower lid using a 5-point scale, where -2 = Unacceptably tight (reduced movement, unacceptable), -1 = Acceptably tight (reduced movement, acceptable), 0 = Optimal fit / movement, +1 = Acceptably loose (excessive movement, acceptable), and +2 = Unacceptably loose (excessive movement, unacceptable). To meet the definition of no re-fit, an eye had to have an acceptable or optimal overall lens fit with the study lens, as well as be within 1 grade of the overall lens fit assessed with the habitual lens at baseline. Proportion of subjects is reported as a percentage. | Dispense (Day 0), Week 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lens fit, contact lenses, myopia