Clinical Evaluation of Two Monthly Contact Lenses
Status: | Completed |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 18 - 35 |
Updated: | 3/7/2019 |
Start Date: | March 7, 2018 |
End Date: | March 26, 2018 |
The purpose of this study is to explore overall vision with BIOFINITY® ENERGYS™ contact
lenses as compared to BIOFINITY® contact lenses after one week of wear.
lenses as compared to BIOFINITY® contact lenses after one week of wear.
Inclusion Criteria:
- Able to understand and sign an approved informed consent form (ICF);
- Successful wear of BIOFINITY® (spherical) (or private label) contact lenses in both
eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
- Best-corrected visual acuity (BCVA) 20/25 or better in each eye;
- Possess spectacles that provide a corrected visual acuity of 20/40 or better in both
eyes (OU) and be willing to wear them (as needed);
- Currently using digital devices (computer, tablet, and/or smart phone) for a minimum
of 5 days per week and 4 hours per day;
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
- Any anterior segment infection, inflammation, abnormality or disease that
contraindicates contact lens wear;
- Any use of systemic or ocular medications for which contact lens wear could be
contraindicated;
- Refractive, ocular, or intraocular surgery, as specified in the protocol;
- Current or history of eye injury or disorders, as specified in the protocol;
- Current or history of intolerance, hypersensitivity or allergy to any component of the
study products;
- Habitual contact lens wear in an extended wear modality (routinely sleeping in lenses
for at least 1 night per week) over the last 3 months prior to enrollment;
- Use of topical ocular medications that would require instillation during contact lens
wear;
- Other protocol-specified exclusion criteria may apply.
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