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 |
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.
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.
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