Two Daily Disposable Contact Lenses in Symptomatic Patients

Alcon

Status: Completed

Conditions: Myopia

Treatments: Device: Delefilcon A contact lenses; Device: Senofilcon A contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT03628599

CLS312-P001

Details and patient eligibility

About

The purpose of this study is to evaluate the performance of DAILIES TOTAL1® and ACUVUE OASYS® 1-DAY and with respect to visual acuity in a symptomatic study population of monthly or bi-weekly replacement lens wearers.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Able to understand and must sign an IRB-approved informed consent form;
• Soft contact lens wearers in both eyes during the past 3 months;
• Best-corrected visual acuity (BCVA) 20/25 or better in each eye;
• Willing to wear study lenses at least 3 days per week and at least 8 hours per day;
• Willing to stop wearing habitual contact lenses for the duration of study participation.

Exclusion criteria

• Infection, inflammation, abnormality, condition, disease, surgery, or use of medications, as specified in the protocol;
• 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;
• Monocular (only one eye with functional vision).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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39 participants in 2 patient groups

TOTAL1

Experimental group

Description:

Delefilcon A contact lenses worn bilaterally (in both eyes) for 4 weeks in a daily disposable modality

Treatment:

Device: Delefilcon A contact lenses

1-DAY

Active Comparator group

Description:

Senofilcon A contact lenses worn bilaterally for 4 weeks in a daily disposable modality

Treatment:

Device: Senofilcon A contact lenses