Clinical Performance of a Silicone Hydrogel for Daily Disposable Wear
Status: | Completed |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/6/2019 |
Start Date: | April 19, 2017 |
End Date: | May 15, 2017 |
The purpose of this study is to compare the visual acuity of an investigational silicone
hydrogel to a commercially available silicone hydrogel in contact lens wearers.
hydrogel to a commercially available silicone hydrogel in contact lens wearers.
Inclusion Criteria:
- Able to understand and sign an IRB-approved Informed Consent Form;
- Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days
per week and 8 hours per day during the past 3 months:
- Manifest cylinder of ≤ 0.75 diopter (D) in each eye;
- Best corrected visual acuity (BCVA) of 20/25 or better in each eye;
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
- Any anterior segment infection, inflammation, abnormality or disease (including
systemic) that contraindicates contact lens wear, as determined by the Investigator;
- Any use of systemic or ocular medications for which contact lens wear could be
contraindicated, as determined by the Investigator;
- History of refractive surgery or plan to have refractive surgery during the study;
- Ocular or intraocular surgery within the previous 12 months or planned during the
study;
- Current or history of pathologically dry eye in either eye that, in the opinion of the
Investigator, would preclude contact lens wear;
- Any previous or current wear of MYDAY;
- Habitually wearing monovision or multifocal lenses during the last 3 months;
- Routinely sleeping in lenses for at least 1 night per week over the last 3 months
prior to enrollment;
- Any use of topical ocular medications and artificial tear or rewetting drops that
would require instillation during contact lens wear;
- Other protocol-defined exclusion criteria may apply.
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