Clinical Assessment of a HYDRAGLYDE® Regimen

Completed · Not applicable

Conditions studied: Refractive Errors, Myopia, Hypermetropia

In brief

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.

Key facts

Study ID

NCT03026257

Run by

Alcon, a Novartis Company

People needed

323

Starts

2017-02-13

Expected to finish

2017-08-18

Last updated by the study team

2018-08-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Alcon Investigative Site — Birmingham, Alabama, United States
• Alcon Investigative Site — Cleveland, Ohio, United States
• Alcon Investigative Site — Columbus, Ohio, United States
• Alcon Investigative Site — Memphis, Tennessee, United States
• Alcon Investigative Site — Houston, Texas, United States
• Alcon Investigative Site — Waterloo, Ontario, Canada
• Alcon Investigative Site — Hildesheim, Germany
• Alcon Investigative Site — Jena, Germany

Full record on ClinicalTrials.gov

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