Comparison of Lotrafilcon B Lenses With Different Packaging Solutions

Study Overview
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Brief Summary
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The purpose of this study is to evaluate AIR OPTIX® plus HYDRAGLYDE® (AOHG) contact lenses compared to AIR OPTIX® AQUA (AOA) contact lenses in overall lens fit.

Detailed Description
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Subjects must not wear any contact lenses prior to the visit on Day 1 (Insertion) for Period 1 or Day 1 (Insertion) for Period 2.

Official Title
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One Month Clinical Comparison of Two Lotrafilcon B Spherical Lenses With Different Packaging Solutions

Conditions
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Refractive Error

Intervention / Treatment
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* Device: Lotrafilcon B contact lenses with EOBO-41
* Device: Lotrafilcon B contact lenses
* Device: Hydrogen peroxide-based lens care solution
* Device: Saline solution for rinsing contact lenses
* Device: Saline solution for rinsing contact lens case


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must sign Informed Consent Document; Manifest cylinder less than or equal to 0.75 Diopter (D) in each eye; Successful current wearer (during the past 2 months for a minimum of 5 days per week and 8 hours per day) of AOA contact lenses within the protocol-specified power range; Willing to answer text messages on a daily basis during the study; Willing to discontinue artificial tears and rewetting drops on the days of study visits; Other protocol-specified inclusion criteria may apply. Exclusion Criteria: Habitual lens wear in an extended wear modality (routinely sleeping in lenses overnight for 1 night per week); Any anterior segment infection, inflammation, disease or abnormality that contraindicates contact lens wear (within 7 days of enrollment, or current); History of herpetic keratitis, corneal surgery or irregular cornea; Any use of systemic or ocular medications for which contact lens wear could be contraindicated; Monocular (only 1 eye with functional vision) or fit with only 1 lens; Pregnant or lactating; Participation in any clinical study within 30 days of Visit 1; Other protocol-specified 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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: AOHG, then AOA<br>Lotrafilcon B contact lenses with EOBO-41 worn first, followed by lotrafilcon B contact lenses worn second. Both products worn bilaterally (in both eyes) for 30 days and removed nightly for care using a hydrogen peroxide-based lens care solution. | Device: Lotrafilcon B contact lenses with EOBO-41<br>* Lotrafilcon B contact lenses packaged with copolymer 845 and EOBO-41<br>* Other names: AOHG;Device: Lotrafilcon B contact lenses<br>* Lotrafilcon B contact lenses packaged with copolymer 845<br>* Other names: AOA;Device: Hydrogen peroxide-based lens care solution<br>* Commercially-available hydrogen peroxide-based lens care solution for cleaning, disinfecting, and storing silicone hydrogel soft contact lenses<br>* Other names: CLEAR CARE® PLUS;Device: Saline solution for rinsing contact lenses<br>* Commercially-available saline solution used as needed<br>* Other names: Minims®;Device: Saline solution for rinsing contact lens case<br>* Commercially-available solution used as needed<br>* Other names: LENS PLUS® OCUPURE™;|
| Other: AOA, then AOHG<br>Lotrafilcon B contact lenses worn first, followed by lotrafilcon B contact lenses with EOBO-41 worn second. Both products worn bilaterally for 30 days and removed nightly for care using a hydrogen peroxide-based lens care solution. | Device: Lotrafilcon B contact lenses with EOBO-41<br>* Lotrafilcon B contact lenses packaged with copolymer 845 and EOBO-41<br>* Other names: AOHG;Device: Lotrafilcon B contact lenses<br>* Lotrafilcon B contact lenses packaged with copolymer 845<br>* Other names: AOA;Device: Hydrogen peroxide-based lens care solution<br>* Commercially-available hydrogen peroxide-based lens care solution for cleaning, disinfecting, and storing silicone hydrogel soft contact lenses<br>* Other names: CLEAR CARE® PLUS;Device: Saline solution for rinsing contact lenses<br>* Commercially-available saline solution used as needed<br>* Other names: Minims®;Device: Saline solution for rinsing contact lens case<br>* Commercially-available solution used as needed<br>* Other names: LENS PLUS® OCUPURE™;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects Satisfying the no Re-fit Criteria in Both Eyes | Overall lens fit was graded by the Investigator on a 5-point scale: -2 (unacceptably tight); -1 (acceptably tight); 0 (optimal fit); +1 (acceptable loose); +2 (unacceptable loose). 'No re-fit' criteria was satisfied if an acceptable or optimal overall lens fit, that was also within one grade of the habitual lens fit value, was achieved. | Day 30, each product | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Ex Vivo Total Cholesterol Uptake After 30 Days of Wear | The contact lens was removed from the eye. Cholesterol deposits were extracted and measured in micrograms (μg) per lens. Lower deposits indicate increased lens performance. Only one eye (right eye) contributed to the analysis. | Day 30, each product | 
| Change From Insertion in Minimum Protected Area (MPA) | MPA (the minimum area of the contact lens surface (expressed in %) protected by the tear film between two natural blinks) was assessed by the Investigator during the interblink period using the Tearscope® lighting system. Higher values indicate a more stable tear film in front of the lens. This Outcome Measure was pre-specified for AOHG only. Both eyes contributed to the analysis. | Hour 0 (Lens Insertion) to Hour 12 on Day 1 |