Clinical Evaluation of ACUVUE® OASYS® 1-Day and ACUVUE® OASYS®



Status:Active, not recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:5/20/2016
Start Date:March 2016
End Date:June 2016

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Clinical Evaluation of ACUVUE® OASYS® 1-Day Daily Disposable Silicone Hydrogel Contact Lenses

The purpose of this study is to evaluate the performance of two commercially-available
silicone hydrogel contact lenses in normal and low humidity environments after at least 7
days of wear.

After randomization, subjects will attend a baseline visit to include a 3 hour exposure to
reduced humidity (RH) environment. The subject's habitual lenses will be worn for the
baseline visit. This trial will be conducted in the United Kingdom.

Inclusion Criteria:

- Must sign an informed consent form;

- Adapted, current soft silicone hydrogel daily disposable contact lens wearer during
the last 2 months;

- Prescription within power range of both study contact lenses, as stated in the
protocol;

- Cylinder equal or lower than -0.75 diopter (D) in both eyes;

- Willing to wear lenses every day or at least a minimum of 5 days per week, 6 hours
per day;

- Willing to discontinue artificial tears and rewetting drops on the days of study
visits;

- Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

- Ocular anterior segment infection, inflammation, abnormality, or active disease that
would contraindicate contact lens wear;

- Use of systemic or ocular medications for which contact lens wear could be
contraindicated as determined by the investigator;

- Monocular (only 1 eye with functional vision) or fit with only 1 lens;

- History of herpetic keratitis, ocular surgery, or irregular cornea;

- Pregnant or lactating;

- Current AO1D or AO lens wearer;

- Other protocol-specified exclusion criteria may apply.
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