Clinical Evaluation of Two Monthly Contact Lenses

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-07

Study Completion Date

2018-03-26

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.

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Detailed Description

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Conditions

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Refractive Errors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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BIOFINITY ENERGYS then BIOFINITY

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.

Group Type OTHER

Comfilcon A with Digital Zone Optics™ contact lenses

Intervention Type DEVICE

Silicone hydrogel spherical contact lenses with Digital Zone Optics™

Comfilcon A contact lenses

Intervention Type DEVICE

Silicone hydrogel spherical contact lenses

BIOFINITY then BIOFINITY ENERGYS

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.

Group Type OTHER

Comfilcon A with Digital Zone Optics™ contact lenses

Intervention Type DEVICE

Silicone hydrogel spherical contact lenses with Digital Zone Optics™

Comfilcon A contact lenses

Intervention Type DEVICE

Silicone hydrogel spherical contact lenses

Interventions

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Comfilcon A with Digital Zone Optics™ contact lenses

Silicone hydrogel spherical contact lenses with Digital Zone Optics™

Intervention Type DEVICE

Comfilcon A contact lenses

Silicone hydrogel spherical contact lenses

Intervention Type DEVICE

Other Intervention Names

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BIOFINITY® ENERGYS™ BIOFINITY®

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;

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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No