DD T2 Daily Disposable Registration Trial

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.

Study Overview

• Status: Completed
• Conditions: Refractive Errors; Myopia
• Intervention / Treatment: Device: verofilcon A contact lenses; Device: delefilcon A contact lenses

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 Type: Interventional
• Enrollment (Actual): 107
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92123
      • Alcon Investigative Site
  • Florida
    • Longwood, Florida, United States, 32779
      • Alcon Investigative Site
    • Maitland, Florida, United States, 32751
      • Alcon Investigative Site
  • Illinois
    • Bloomington, Illinois, United States, 61701
      • Alcon Investigative Site
  • Tennessee
    • Brentwood, Tennessee, United States, 37027
      • Alcon Investigative Site
    • Memphis, Tennessee, United States, 38111
      • Alcon Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DD T2; 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.	Device: verofilcon A contact lenses; Daily disposable soft contact lenses; Other Names: DD T2
Active Comparator: DT 1; 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.	Device: delefilcon A contact lenses; Daily disposable soft contact lenses; Other Names: DAILIES TOTAL1®; DT1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Dispense, Week 1, Week 2, Month 1, Month 2, Month 3

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Alcon, A Novartis Division, Alcon, A Novartis Division

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2017
• Primary Completion (Actual): February 21, 2018
• Study Completion (Actual): February 21, 2018

Study Registration Dates

• First Submitted: October 5, 2017
• First Submitted That Met QC Criteria: October 5, 2017
• First Posted (Actual): October 10, 2017

Study Record Updates

• Last Update Posted (Actual): February 22, 2019
• Last Update Submitted That Met QC Criteria: January 30, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: vision; soft contact lenses; eyesight
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: CLE383-C005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No