Performance Evaluation of Different Daily Disposable Silicone Hydrogel Contact Lenses

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

Study Overview

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

Detailed Description

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

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

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2L 3S1
      • Insight Eye Care
• United States
  • Florida
    • Ocoee, Florida, United States, 34761
      • Coan Eye Care
  • New York
    • Vestal, New York, United States, 13850
      • Sacco Eye Group, PLLC
  • Ohio
    • Granville, Ohio, United States, 43023
      • ProCare Vision Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Is between 18 and 35 years of age (inclusively) and has full legal capacity to volunteer;
2. Has read and signed an information consent letter;
3. Self-reports having a full eye examination in the previous two years;
4. Anticipates being able to wear the study lenses for at least 8 hours a day, 7 days a week;
5. Is willing and able to follow instructions and maintain the appointment schedule;

6. 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.
7. Has refractive astigmatism no higher than -0.75DC in each eye;
8. 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:

1. Is participating in any concurrent clinical or research study;
2. Has any known active ocular disease and/or infection that contraindicates contact lens wear;
3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
4. Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable;
5. Has known sensitivity to the diagnostic sodium fluorescein used in the study;
6. Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;
7. 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 Contact Lens, Then Test Contact Lens; Participants will wear control contact lenses for one week and then crossover to test contact lenses for one week.	Device: Control Contact Lens (stenfilcon A); one week wear; Device: Test Contact Lens (senofilcon A); one week of wear
Experimental: Test Contact Lens, Then Control Contact Lens; Participants will wear test contact lenses for one week and then crossover to control contact lenses for one week.	Device: Control Contact Lens (stenfilcon A); one week wear; Device: Test Contact Lens (senofilcon A); one week of wear

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lens Handling on Removal	Lens Handling on Removal, using 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: Katherine Bickle, ProCare Vision Center; Principal Investigator: Carolyn MacNeil, Insight Eye Care; Principal Investigator: Roxanne Achong-Coan, Coan Eye Care; Principal Investigator: Andrew Sacco, Sacco Eye Group, PLLC

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2023
• Primary Completion (Actual): June 20, 2023
• Study Completion (Actual): June 20, 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): September 26, 2024
• Last Update Submitted That Met QC Criteria: September 20, 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-145

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