Clinical Evaluation of Two Monthly Contact Lenses

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Evaluation of Two Monthly Contact Lenses

Conditions
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Refractive Errors

Intervention / Treatment
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* Device: Comfilcon A with Digital Zone Optics™ contact lenses
* Device: Comfilcon A contact lenses


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: BIOFINITY ENERGYS then BIOFINITY<br>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. | Device: Comfilcon A with Digital Zone Optics™ contact lenses<br>* Silicone hydrogel spherical contact lenses with Digital Zone Optics™<br>* Other names: BIOFINITY® ENERGYS™;Device: Comfilcon A contact lenses<br>* Silicone hydrogel spherical contact lenses<br>* Other names: BIOFINITY®;|
| Other: BIOFINITY then BIOFINITY ENERGYS<br>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. | Device: Comfilcon A with Digital Zone Optics™ contact lenses<br>* Silicone hydrogel spherical contact lenses with Digital Zone Optics™<br>* Other names: BIOFINITY® ENERGYS™;Device: Comfilcon A contact lenses<br>* Silicone hydrogel spherical contact lenses<br>* Other names: BIOFINITY®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Rating of Overall Vision | 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. | Day 7, each product | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Over-refraction | 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. | Day 1 (Dispense), each product |