Status:
COMPLETED
Clinical Evaluation of Two Monthly Contact Lenses
Lead Sponsor:
Alcon Research
Conditions:
Refractive Errors
Eligibility:
All Genders
18-35 years
Phase:
NA
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 26 2018
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03459131
Start Date
March 7 2018
End Date
March 26 2018
Last Update
March 5 2019
Active Locations (1)
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1
Alcon Investigative Site
Maitland, Florida, United States, 32751