Clinical Evaluation of Two Monthly Contact Lenses

Alcon

Status: Completed

Conditions: Refractive Errors

Treatments: Device: Comfilcon A contact lenses; Device: Comfilcon A with Digital Zone Optics™ contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT03459131

CLD523-E001

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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15 participants in 2 patient groups

BIOFINITY ENERGYS then BIOFINITY

Other group

Description:

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.

Treatment:

Device: Comfilcon A with Digital Zone Optics™ contact lenses

Device: Comfilcon A contact lenses

BIOFINITY then BIOFINITY ENERGYS

Other group

Description:

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.

Treatment:

Device: Comfilcon A with Digital Zone Optics™ contact lenses

Device: Comfilcon A contact lenses