Performance Evaluation of Daily Disposable Contact Lenses in Habitual Lens Wearers Who Use Digital Devices Frequently

Performance Evaluation of Different Daily Disposable Contact Lenses in Habitual Lens Wearers Who Report Frequent Use of Digital Devices

The goal of this study is to compare the performance of two daily disposable silicone hydrogel lenses.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Control Lens (stenfilcon A); Device: Test Lens (senofilcon A)

Detailed Description

This study is prospective, bilateral eye, double masked, randomized, 1 week cross-over, daily wear design involving in two different daily disposable lens types. Each lens type will be worn for approximately one week.

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Pittsburg, Kansas, United States, 66762
      • Kannarr Eye Care
  • Minnesota
    • Medina, Minnesota, United States, 55340
      • Complete Eye Care of Medina
  • Pennsylvania
    • State College, Pennsylvania, United States, 16801
      • Nittany Eye Associates
  • Rhode Island
    • Warwick, Rhode Island, United States, 02888
      • West Bay Eye Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Is between 18 and 35 years of age (inclusively) and has full legal capacity to volunteer;
• Has read and signed an information consent letter;
• Self-reports having a full eye examination in the previous two years;
• Self-reports spending on most days at least 6 hours cumulative (not necessarily in one single stretch) using digital devices such as a computer, laptop, tablet, e-reader, smartphone;
• Anticipates being able to wear the study lenses for at least 8 hours a day, 7 days a week;
• Is willing and able to follow instructions and maintain the appointment schedule;

• Habitually wears soft contact lenses, for the past 3 months minimum;

  1. No more than 1/3 of participants should be habitual wearer of MyDay or MyDay Energys
  2. No more than 1/3 of participants should be habitual wearer of ACUVUE® OASYS MAX 1-Day or ACUVUE® OASYS 1-Day.
• Has refractive astigmatism no higher than -0.75DC in each eye;
• Can be fit and achieve binocular distance vision of at least 20/30 Snellen (Available lens parameters are sphere -1.00 to -6.00D, 0.25D steps).

Exclusion Criteria:

• Is participating in any concurrent clinical or research study;
• Has any known active ocular disease and/or infection that contraindicates contact lens wear;
• Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
• Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable;
• Has known sensitivity to the diagnostic sodium fluorescein used in the study;
• Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;
• Has undergone refractive error surgery or intraocular surgery.

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
Experimental: Control Lens, Then Test Lens; Participants will wear control lenses for one week and then crossover to test lenses for one week.	Device: Control Lens (stenfilcon A); One week wear; Device: Test Lens (senofilcon A); One week wear
Experimental: Test Lens, Then Control Lens; Participants will wear test lenses for one week and then crossover to control lenses for one week.	Device: Control Lens (stenfilcon A); One week wear; Device: Test Lens (senofilcon A); One week wear

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lens Handling on Removal	Ease of lens removal on a 0-100 scale (0= very difficult, 100= very easy)	Collected once on day 6 at the end of wear

Collaborators and Investigators

• Sponsor: CooperVision, Inc.
• Collaborators: Centre for Ocular Research & Education, Canada
• Investigators: Principal Investigator: Shane Kannarr, Kannarr Eye Care; Principal Investigator: Michael Cymbor, Nittany Eye Associates; Principal Investigator: Gina Wesley, Complete Eye Care of Medina; Principal Investigator: Stephen Montaquila, West Bay Eye Associates

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2023
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: March 28, 2023
• First Submitted That Met QC Criteria: March 28, 2023
• First Posted (Actual): April 7, 2023

Study Record Updates

• Last Update Posted (Actual): June 25, 2024
• Last Update Submitted That Met QC Criteria: May 30, 2024
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: EX-MKTG-148

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.: Yes