DD T2 Daily Disposable Registration Trial

Not Applicable

Completed

• Conditions: Myopia; Refractive Errors
• Interventions: Device: delefilcon A contact lenses; Device: verofilcon A contact lenses

• Registration Number: NCT03305770
• Lead Sponsor: Alcon Research

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-10-05
• Study First Submitted QC: 2017-10-05
• Study First Posted: 2017-10-10
• Study Start: 2017-10-12
• Primary Completion: 2018-02-21
• Study Completion: 2018-02-21
• Status Verified: 2019-01
• Results First Submitted: 2019-01-30
• Results First Submitted QC: 2019-01-30
• Last Update Submitted: 2019-01-30
• Results First Posted: 2019-02-22
• Last Update Posted: 2019-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DT 1	delefilcon A contact lenses	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.
DD T2	verofilcon A contact lenses	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.

Primary Outcome Measures

Name	Time	Method
Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen)	Dispense, Week 1, Week 2, Month 1, Month 2, Month 3	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.

Trial Locations

Locations (1)

Alcon Investigative Site; 🇺🇸 Memphis, Tennessee, United States