Clinical Evaluation of Two Monthly Contact Lenses

Not Applicable

Completed

Interventions: Device: Comfilcon A with Digital Zone Optics™ contact lenses
Device: Comfilcon A contact lenses

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
BIOFINITY ENERGYS then BIOFINITY	Comfilcon A contact lenses	Comfilcon A with Digital Zone Optics™ contact lenses worn first, followed by comfilcon A contact lenses. Each product will be worn bilaterally (in both eyes) for 7 days in a daily wear modality.
BIOFINITY then BIOFINITY ENERGYS	Comfilcon A contact lenses	Comfilcon A contact lenses worn first, followed by comfilcon A with Digital Zone Optics™ contact lenses. Each product will be worn bilaterally (in both eyes) for 7 days in a daily wear modality.
BIOFINITY ENERGYS then BIOFINITY	Comfilcon A with Digital Zone Optics™ contact lenses	Comfilcon A with Digital Zone Optics™ contact lenses worn first, followed by comfilcon A contact lenses. Each product will be worn bilaterally (in both eyes) for 7 days in a daily wear modality.
BIOFINITY then BIOFINITY ENERGYS	Comfilcon A with Digital Zone Optics™ contact lenses	Comfilcon A contact lenses worn first, followed by comfilcon A with Digital Zone Optics™ contact lenses. Each product will be worn bilaterally (in both eyes) for 7 days in a daily wear modality.

Primary Outcome Measures

Name	Time	Method
Subjective Rating of Overall Vision	Day 7, each product	Overall vision was assessed binocularly (both eyes together) by the subject on a 10-point scale, where 1=poor and 10=excellent. Inferential testing was not planned for this primary effectiveness endpoint.

Secondary Outcome Measures

Name	Time	Method
Over-refraction	Day 1 (Dispense), each product	Over-refraction (amount of additional correction needed to improve visual acuity (VA)) was collected for each eye and measured in diopters (D). Inferential testing was not planned for this endpoint.