DD T2 Daily Disposable Registration Trial

Alcon

Status: Completed

Conditions: Myopia; Refractive Errors

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03305770

CLE383-C005

Details and patient eligibility

About

The purpose of this study is to evaluate the performance of the investigational verofilcon A contact lens compared to the commercially available delefilcon A contact lens, by assessing visual acuity as the primary variable.

Full description

Enrolled participants will be randomized (2:1) to receive either verofilcon A (test) contact lenses or delefilcon A (control) contact lenses for wear in both eyes and attend 7 office visits: Baseline, Dispense, 1-week follow-up, 2-week follow-up, 1-month follow-up, 2-month follow-up and 3-month follow-up/Exit.

Enrollment: 107 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• 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 20/25 or better in each eye.
• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria

• Any current or prior wear experience with DT1 lenses.
• 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.
• 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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107 participants in 2 patient groups

DD T2

Experimental group

Description:

Verofilcon A contact lenses worn in both eyes for 3 months in a daily wear, daily disposable modality. A new pair of study lenses will be inserted each day and discarded at the end of the day.

Treatment:

Device: verofilcon A contact lenses

DT 1

Active Comparator group

Description:

Delefilcon A contact lenses worn in both eyes for 3 months in a daily wear, daily disposable modality. A new pair of study lenses will be inserted each day and discarded at the end of the day.

Treatment:

Device: delefilcon A contact lenses