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Clinical Assessment of a Regimen of AIR OPTIX® Plus HYDRAGLYDE® Silicone Hydrogel Lenses and HYDRAGLYDE® Containing Lens Care Solutions (NCT03026257)

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.
  • Device: Lotrafilcon B contact lenses with added wetting agent
    Silicone hydrogel contact lenses
    • AIR OPTIX® plus HYDRAGLYDE® (AOHG)
  • Device: Samfilcon A contact lenses
    Habitual silicone hydrogel contact lenses
    • Bausch + Lomb ULTRA™ (Ultra)
  • Device: POLYQUAD/ALDOX-preserved contact lens solution with added wetting agent
    Multi-purpose disinfecting solution for contact lens care
    • OPTI-FREE® PureMoist® (OFPM)
  • Device: Hydrogen peroxide-based contact lens solution with added wetting agent
    Solution for contact lens cleaning and disinfecting
    • CLEAR CARE® PLUS/AOSEPT® PLUS with HYDRAGLYDE® (CCP)
  • Device: Senofilcon C contact lenses
    Habitual silicone hydrogel contact lenses
    • Johnson & Johnson ACUVUE® VITA™ (Vita)
  • Device: Senofilcon A contact lenses
    Habitual silicone hydrogel contact lenses
    • Johnson & Johnson ACUVUE® OASYS® 2- Week with HYDRACLEAR® PLUS (Oasys)
  • Device: Comfilcon A contact lenses
    Habitual silicone hydrogel contact lenses
    • CooperVision® Biofinity® (Biofinity)
  • Device: Habitual Multi-Purpose Solution (HMPS)
    Multi-purpose solution for contact lens care according to participant's habitual brand, used per manufacturer's instructions
    Ages eligible for Study
    18 Years and older
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    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®, XiidraTM 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.

    8 locations

    Status:
    recruiting
    Type:
    Interventional
    Phase:
    -
    Start:
    12 February, 2017
    Updated:
    27 June, 2017
    Participants:
    256
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