Clinical Assessment of a HYDRAGLYDE® Regimen

Study Overview
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Brief Summary
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The purpose of this study is to evaluate worn AIR OPTIX® plus HYDRAGLYDE® (AOHG) lenses cleaned and disinfected with HYDRAGLYDE® containing lens solutions compared to each of the control habitual silicone hydrogel (SiHy) lenses cleaned and disinfected with habitual multi-purpose solution (MPS) for cholesterol uptake.

Official Title
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Clinical Assessment of a Regimen of AIR OPTIX® Plus HYDRAGLYDE® Silicone Hydrogel Lenses and HYDRAGLYDE® Containing Lens Care Solutions

Conditions
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Myopia, Hypermetropia, Refractive Errors

Intervention / Treatment
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* Device: Lotrafilcon B contact lenses with added wetting agent
* Device: Samfilcon A contact lenses
* Device: POLYQUAD/ALDOX-preserved contact lens solution with added wetting agent
* Device: Hydrogen peroxide-based contact lens solution with added wetting agent
* Device: Senofilcon C contact lenses
* Device: Senofilcon A contact lenses
* Device: Comfilcon A contact lenses
* Device: Habitual Multi-Purpose Solution (HMPS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must sign informed consent document; Vision correctable to 0.1 (LogMAR) or better in each eye at distance with habitual lenses; Manifest cylinder (at screening) less than or equal to 0.75 diopter (D) in each eye and spectacle add <+0.50 D in each eye; Current full-time wearer of spherical samfilcon A, comfilcon A, senofilcon C monthly or senofilcon A 2-week replacement lens within the power range of lens powers available; Current user of an MPS (excluding OFPM) to care for lenses; Willing to answer text messages on a daily basis during the study; Willing to discontinue artificial tears during the study and rewetting drops on the days of study visits; Use of digital devices (eg, smart phone, tablet, laptop or desktop computer) for 20 consecutive minutes at least twice a week and willing to continue for the duration of the study; Other protocol specific inclusion criteria may apply. Exclusion Criteria: Habitual lens wear in an extended wear modality (routinely sleeping in lenses overnight for 1 or more nights per week); Any anterior segment infection, inflammation, disease or abnormality that contraindicates contact lens wear; History of herpetic keratitis, corneal surgery or irregular cornea; Prior refractive surgery; Any use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator; Currently using or have not discontinued Restasis®, Xiidra™ and/or topical steroids within the past 7 days; Use of mechanical eyelid therapy or eyelid scrubs within 14 days before Visit 1 and not willing to discontinue during the study; Monocular (only 1 eye with functional vision) or fit with only 1 lens; Known pregnancy or lactating; Other protocol specific 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AOHG<br>Lotrafilcon B contact lenses with added wetting agent, worn bilaterally (in both eyes) for 30 days in a daily wear modality and cared for with either a hydrogen peroxide-based contact lens solution with added wetting agent or a POLYQUAD/ALDOX-preserved contact lens solution with added wetting agent, as randomized | Device: Lotrafilcon B contact lenses with added wetting agent<br>* Silicone hydrogel contact lenses<br>* Other names: AIR OPTIX® plus HYDRAGLYDE® (AOHG);Device: POLYQUAD/ALDOX-preserved contact lens solution with added wetting agent<br>* Multi-purpose disinfecting solution for contact lens care<br>* Other names: OPTI-FREE® PureMoist® (OFPM);Device: Hydrogen peroxide-based contact lens solution with added wetting agent<br>* Solution for contact lens cleaning and disinfecting<br>* Other names: CLEAR CARE® PLUS/AOSEPT® PLUS with HYDRAGLYDE® (CCP);|
| Active Comparator: Habitual<br>Habitual silicone hydrogel contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual multi-purpose solution (MPS) | Device: Samfilcon A contact lenses<br>* Habitual silicone hydrogel contact lenses<br>* Other names: Bausch + Lomb ULTRA™ (Ultra);Device: Senofilcon C contact lenses<br>* Habitual silicone hydrogel contact lenses<br>* Other names: Johnson & Johnson ACUVUE® VITA™ (Vita);Device: Senofilcon A contact lenses<br>* Habitual silicone hydrogel contact lenses with a replacement pair issued after 2 weeks<br>* Other names: Johnson & Johnson ACUVUE® OASYS® 2- Week with HYDRACLEAR® PLUS (Oasys);Device: Comfilcon A contact lenses<br>* Habitual silicone hydrogel contact lenses<br>* Other names: CooperVision® Biofinity® (Biofinity);Device: Habitual Multi-Purpose Solution (HMPS)<br>* Multi-purpose solution for contact lens care according to participant's habitual brand, used per manufacturer's instructions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ex Vivo Total Cholesterol Uptake at Day 30 | The contact lens worn in the right eye was removed and stored dry and frozen until analysis. Total cholesterol uptake (cholesterol and cholesterol esters) was evaluated from a sample of the right contact lenses from each site and measured in micrograms. Lower total cholesterol uptake indicates increased lens performance. | Day 30 |