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OpenTrials
Completed

NCT Number: NCT03026257

Clinical Assessment of a HYDRAGLYDE® Regimen

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alcon Investigative Site, Waterloo, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lotrafilcon B contact lenses with added wetting agent

Device

Silicone hydrogel contact lenses

Other names: AIR OPTIX® plus HYDRAGLYDE® (AOHG)

Samfilcon A contact lenses

Device

Habitual silicone hydrogel contact lenses

Other names: Bausch + Lomb ULTRA™ (Ultra)

POLYQUAD/ALDOX-preserved contact lens solution with added wetting agent

Device

Multi-purpose disinfecting solution for contact lens care

Other names: OPTI-FREE® PureMoist® (OFPM)

Hydrogen peroxide-based contact lens solution with added wetting agent

Device

Solution for contact lens cleaning and disinfecting

Other names: CLEAR CARE® PLUS/AOSEPT® PLUS with HYDRAGLYDE® (CCP)

Senofilcon C contact lenses

Device

Habitual silicone hydrogel contact lenses

Other names: Johnson & Johnson ACUVUE® VITA™ (Vita)

Senofilcon A contact lenses

Device

Habitual silicone hydrogel contact lenses with a replacement pair issued after 2 weeks

Other names: Johnson & Johnson ACUVUE® OASYS® 2- Week with HYDRACLEAR® PLUS (Oasys)

Comfilcon A contact lenses

Device

Habitual silicone hydrogel contact lenses

Other names: CooperVision® Biofinity® (Biofinity)

Habitual Multi-Purpose Solution (HMPS)

Device

Multi-purpose solution for contact lens care according to participant's habitual brand, used per manufacturer's instructions

Primary outcomes

  1. Ex Vivo Total Cholesterol Uptake at Day 30

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Alcon, a Novartis Company

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 20, 2017
Registry last updated
Aug 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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