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

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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.


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.
We found this trial at
1
site
Maitland, Florida 32751
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from
Maitland, FL
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