Clinical Comparison of 4 Daily Disposable Soft Contact Lenses

The purpose of this study is to obtain on-eye performance data to inform contact lens product development and to further evaluate product performance in the intended population.

Study Overview

• Status: Completed
• Conditions: Refractive Error
• Intervention / Treatment: Device: verofilcon A contact lenses; Device: senofilcon A contact lenses; Device: stenfilcon A contact lenses; Device: etafilcon A contact lenses

Detailed Description

The expected duration of subject participation in the study is approximately 20 days with 3 scheduled visits. Each subject will evaluate the test contact lenses compared to 1 of 3 commercially available contact lenses.

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Maitland, Florida, United States, 32751
      • Alcon Investigative Site
    • Pensacola, Florida, United States, 32503
      • Alcon Investigative Site
  • Georgia
    • Johns Creek, Georgia, United States, 30097
      • 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

Inclusion Criteria:

• Able to understand and must sign an approved Informed Consent Form
• Successfully wears daily disposable spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months
• Best Corrected Visual Acuity of 20/25 Snellen or better in each eye
• Willing to stop wearing habitual contact lenses for the duration of study participation
• Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

• Any eye condition, surgery, disease, or use of medication that contraindicates contact lens wear, as determined by the Investigator.
• Routinely sleeps in habitual contact lenses
• Currently wears Oasys 1-Day, MyDay, or Moist contact lenses
• Other protocol-defined exclusion criteria may apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: DD T2/Oasys 1-Day; Verofilcon A contact lenses and senofilcon A contact lenses worn in both eyes, each product, for 1 week on a daily wear basis, as randomized	Device: verofilcon A contact lenses; Investigational spherical silicone hydrogel contact lenses for daily disposable wear; Other Names: DDT2; Device: senofilcon A contact lenses; Commercially available spherical silicone hydrogel contact lenses for daily disposable wear; Other Names: ACUVUE OASYS® 1-Day with HydraLuxe™ Technology; Oasys 1-Day
OTHER: DD T2/MyDay; Verofilcon A contact lenses and stenfilcon A contact lenses worn in both eyes, each product, for 1 week on a daily disposable basis, as randomized	Device: verofilcon A contact lenses; Investigational spherical silicone hydrogel contact lenses for daily disposable wear; Other Names: DDT2; Device: stenfilcon A contact lenses; Commercially available spherical silicone hydrogel contact lenses for daily disposable wear; Other Names: MyDay®; MyDay
OTHER: DD T2/Moist; Verofilcon A contact lenses and etafilcon A contact lenses worn in both eyes, each product, for 1 week on a daily disposable basis, as randomized	Device: verofilcon A contact lenses; Investigational spherical silicone hydrogel contact lenses for daily disposable wear; Other Names: DDT2; Device: etafilcon A contact lenses; Commercially available spherical silicone hydrogel contact lenses for daily disposable wear; Other Names: 1-Day ACUVUE® MOIST; Moist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Quality of Vision	Overall quality of vision was collected binocularly and rated on a 10-point scale with 1 = poor to 10 = excellent. Subjects were asked "Thinking back over the last week, please rate our study lenses. Rate eyes together." No formal hypotheses was conducted; hence no inferential testing was performed.	Day 8, each product

Collaborators and Investigators

• Sponsor: Alcon Research

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 10, 2018
• Primary Completion (ACTUAL): February 16, 2018
• Study Completion (ACTUAL): February 16, 2018

Study Registration Dates

• First Submitted: November 17, 2017
• First Submitted That Met QC Criteria: November 17, 2017
• First Posted (ACTUAL): November 21, 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: Myopia; Contact lenses; Near-sighted; Daily disposable
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: CLE383-C004

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