Clinical Comparison of DDT2 Contact Lens and a Daily Disposable Contact Lens - Study 1

The purpose of this study was to evaluate visual acuity at distance when wearing DDT2 contact lenses compared to Acuvue Moist contact lenses.

Study Overview

• Status: Completed
• Conditions: Refractive Error; Myopia
• Intervention / Treatment: Device: Verofilcon A contact lenses; Device: Etafilcon A contact lenses

Detailed Description

Subjects were expected to attend 3 study visits and wear study lenses for approximately 14 - 20 days (7 - 10 days for each product).

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32256
      • Alcon Investigative Site
    • Maitland, Florida, United States, 32751
      • Alcon Investigative Site
    • Orlando, Florida, United States, 32803
      • Alcon Investigative Site
  • Ohio
    • Powell, Ohio, United States, 43065
      • Alcon Investigative Site
  • Tennessee
    • Memphis, Tennessee, United States, 38111
      • Alcon Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key Inclusion Criteria:

• Able to understand and sign an Informed Consent Form that has been approved by an Institutional Review Board.
• Willing and able to attend all scheduled study visits as required per protocol.
• Current wearer of spherical soft contact lenses.

Key Exclusion Criteria:

• Any ocular condition that contraindicates contact lens wear.
• Previous or current habitual wearer of ACUVUE® MOIST or DAILIES TOTAL1® contact lenses.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: DDT2, then 1DAVM; Verofilcon A contact lenses worn first, with etafilcon A contact lenses worn second, as randomized. Each product was worn bilaterally (in both eyes) for 8 -1/+2 days in a daily disposable modality.	Device: Verofilcon A contact lenses; Investigational daily disposable soft contact lenses; Other Names: DDT2; Device: Etafilcon A contact lenses; Commercially available daily disposable soft contact lenses; Other Names: 1DAVM; 1-DAY ACUVUE® MOIST
Other: 1DAVM, then DDT2; Etafilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each product was worn bilaterally (in both eyes) for 8 -1/+2 days in a daily disposable modality.	Device: Verofilcon A contact lenses; Investigational daily disposable soft contact lenses; Other Names: DDT2; Device: Etafilcon A contact lenses; Commercially available daily disposable soft contact lenses; Other Names: 1DAVM; 1-DAY ACUVUE® MOIST

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Least Squares Mean Distance Visual Acuity With Study Lenses	Visual acuity was assessed and collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity.	Day 8, each product

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: CDMA Project Lead, Vision Care, Alcon Research

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2019
• Primary Completion (Actual): June 24, 2019
• Study Completion (Actual): June 24, 2019

Study Registration Dates

• First Submitted: March 22, 2019
• First Submitted That Met QC Criteria: March 22, 2019
• First Posted (Actual): March 25, 2019

Study Record Updates

• Last Update Posted (Actual): June 25, 2020
• Last Update Submitted That Met QC Criteria: June 22, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Visual acuity; Daily disposable contact lenses; VA
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: CLE383-C007

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