Evaluation of the Performance of Monthly Replacement Sphere Lens Designs in Habitual Soft Contact Lens Wearers

The objective of the study is to evaluate the clinical performance of two monthly silicone hydrogel contact lenses in habitual wearers of frequent replacement (FRP) lenses when worn for one month.

Study Overview

• Status: Completed
• Conditions: Myopia; Hyperopia
• Intervention / Treatment: Device: Lens A (comfilcon A lens); Device: Lens B (lehfilcon A lens)

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Medina, Minnesota, United States, 55340
      • Complete Eye Care of Medina
  • New York
    • Vestal, New York, United States, 13850
      • Sacco Eye Group
  • Ohio
    • Athens, Ohio, United States, 45701
      • Athens Eye Care
    • 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
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Is at least 18 years of age and no older than 35 years, and has full legal capacity to volunteer;
• Has read and signed an information consent letter;
• Is willing and able to follow instructions and maintain the appointment schedule;
• 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;
• Has healthy eyes with no health condition or medication that contra-indicate contact lens wear, in the opinion of the investigator;
• Anticipates being able to wear the study lenses for at least 8 hours a day, 6 days a week;
• Habitually wears soft frequent replacement contact lenses, for the past 3 months minimum (NOTE: the habitual contact lens brand is restricted such that no more than one third are to be the Biofinity brand (or their equivalent private label brand name) and no more than one third are to be an Alcon brand;
• 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 +6.00 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 or ocular 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: Lens A, Then Lens B; Participants will wear Lens A for one month and then cross over to wear Lens B for one month.	Device: Lens A (comfilcon A lens); 1 month; Device: Lens B (lehfilcon A lens); 1 month
Experimental: Lens B, Then Lens A; Participants will wear Lens B for one month and then cross over to wear Lens A for one month.	Device: Lens A (comfilcon A lens); 1 month; Device: Lens B (lehfilcon A lens); 1 month

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Ratings on Lens Handling on Removal	Subjective Ratings on Lens handling on removal (0-10 scale, 0.5 steps; 10=very easy, 0=very difficult)	Day 27

Collaborators and Investigators

• Sponsor: Coopervision, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2021
• Primary Completion (Actual): April 22, 2022
• Study Completion (Actual): April 22, 2022

Study Registration Dates

• First Submitted: October 29, 2021
• First Submitted That Met QC Criteria: October 29, 2021
• First Posted (Actual): November 10, 2021

Study Record Updates

• Last Update Posted (Actual): April 4, 2023
• Last Update Submitted That Met QC Criteria: March 9, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Hyperopia
• Other Study ID Numbers: EX-MKTG-129

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