Clinical Assessment of a HYDRAGLYDE® Regimen



Status:Completed
Conditions:Ocular, Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:8/16/2018
Start Date:February 13, 2017
End Date:August 18, 2017

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

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.


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.
We found this trial at
6
sites
Waterloo, Ontario
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Waterloo,
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Birmingham, Alabama 35233
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Birmingham, AL
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Cleveland, Ohio 44106
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Cleveland, OH
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Columbus, Ohio 43210
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Columbus, OH
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Houston, Texas 77204
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Houston, TX
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Memphis, Tennessee 38104
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Memphis, TN
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