Clinical Comparison of Two Daily Disposable Soft Contact Lenses

Alcon

Status: Completed

Conditions: Myopia; Refractive Errors

Treatments: Device: somofilcon A contact lenses; Device: verofilcon A contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT03518008

CLE383-C006

Details and patient eligibility

About

The purpose of this study is to evaluate the overall performance of investigational contact lenses (DD T2) when compared to clariti® 1 day contact lenses.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Understand and sign an Informed Consent Form;
• Successful wear of daily disposable spherical soft 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;
• Willing to stop wearing habitual contact lenses for the duration of study participation;
• Other protocol-specified inclusion criteria may apply.

Exclusion criteria

• Anterior segment infection, inflammation, or abnormality or disease that contraindicates contact lens wear, as determined by the Investigator;
• Use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator;
• Refractive, ocular, or intraocular surgery, as specified in the protocol;
• Eye condition or injury, as specified in the protocol;
• Current or history of intolerance, hypersensitivity, or allergy to any component of the study products;
• Wearing habitual contact lenses 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 and artificial tear or rewetting drops requiring instillation during contact lens wear;
• Currently wearing clariti® 1 day contact lenses;
• Habitually wearing monovision or multifocal lenses during the last 3 months;
• 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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22 participants in 2 patient groups

DD T2, then Clariti 1 Day

Other group

Description:

Verofilcon A contact lenses worn first, with somofilcon A contact lenses worn second. Each product worn bilaterally (in both eyes) for 1 week in a daily disposable modality.

Treatment:

Device: verofilcon A contact lenses

Device: somofilcon A contact lenses

Clariti 1 Day, then DD T2

Other group

Description:

Somofilcon A contact lenses worn first, with verofilcon A contact lenses worn second. Each product worn bilaterally for 1 week in a daily disposable modality.

Treatment:

Device: verofilcon A contact lenses

Device: somofilcon A contact lenses