Clinical Performance of Two Daily Disposable Contact Lenses - Study 1

Alcon

Status: Completed

Conditions: Refractive Errors

Treatments: Device: Verofilcon A contact lenses; Device: Etafilcon A contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT03969290

CLE383-P001

Details and patient eligibility

About

The purpose of this study is to evaluate end of day (EOD) visual acuity (VA) at distance when wearing Precision1™ contact lenses compared to Acuvue® Moist contact lenses.

Full description

The expected duration of subject participation in the study is 1-8 days, with 3 scheduled visits (Screening, Dispense, Exit).

Enrollment: 69 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Able to understand and sign an approved Informed Consent form
• Successful wear of spherical soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day
• Best corrected VA of logMAR 0.10 or better in each eye
• Willing to discontinue artificial tears and rewetting drops during the study
• Able to wear contact lenses within the protocol-specified sphere power range
• Other protocol-specified inclusion criteria may apply.

Exclusion criteria

• Any anterior segment infection, inflammation, or abnormality or disease that contraindicates contact lens wear, as determined by the Investigator
• Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator
• History of ocular or intraocular surgery, including refractive surgery, and/or irregular cornea
• 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
• Previous 3 years or current wearers of Acuvue Moist or DAILIES TOTAL1® contact lenses
• Other protocol-specified exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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69 participants in 2 patient groups

Sequence 1

Experimental group

Description:

Verofilcon A contact lens in the right eye (OD), with etafilcon A contact lens in the left eye (OS), as randomized. Lenses will be worn for one day, approximately 8 hours.

Treatment:

Device: Etafilcon A contact lenses

Device: Verofilcon A contact lenses

Sequence 2

Active Comparator group

Description:

Etafilcon A contact lens in the right eye (OD), with verofilcon A contact lens in the left eye (OS), as randomized. Lenses will be worn for one day, approximately 8 hours.

Treatment:

Device: Etafilcon A contact lenses

Device: Verofilcon A contact lenses