DD T2 Daily Disposable Registration Trial

Alcon Research107 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

107

Conditions

Myopia Refractive Errors

Interventions

verofilcon A contact lensesDEVICE

Daily disposable soft contact lenses

delefilcon A contact lensesDEVICE

Daily disposable soft contact lenses

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (6)

Alcon Investigative Site

San Diego, California, United States

Alcon Investigative Site

Longwood, Florida, United States

Alcon Investigative Site

Maitland, Florida, United States

Alcon Investigative Site

Bloomington, Illinois, United States

Outcomes

Primary Outcomes

Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen)

VA was assessed for each eye individually using a Snellen chart at a distance of 4 meters. A 20/20 Snellen acuity is considered normal distance eyesight. No formal hypotheses were formulated; hence no inferential testing was performed.

Time frame: Dispense, Week 1, Week 2, Month 1, Month 2, Month 3

Data from ClinicalTrials.gov

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