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 |
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.
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.
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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