Performance Evaluation of Two Daily Disposable Toric Lens Designs in Habitual Soft Contact Lens Wearers

The objective of the study is to compare the clinical performance of two different daily disposable, SiHy toric contact lens types, Lens A and Lens B, in existing soft lens wearers when worn for one week each.

Study Overview

• Status: Completed
• Conditions: Astigmatism
• Intervention / Treatment: Device: Lens A; Device: Lens B

Detailed Description

This study is a prospective, bilateral eye, double-masked, randomized, 1-week cross-over, daily-wear design involving two different daily disposable toric lens types. Each lens type will be worn for approximately one week, during which participants record their subjective lens-wear experience.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Whittier, California, United States, 90606
      • Golden Optometric Group
  • Florida
    • Sarasota, Florida, United States, 34237
      • Golden Vision
  • New York
    • Vestal, New York, United States, 13850
      • Sacco Eye Group
  • Ohio
    • Athens, Ohio, United States, 45701
      • Athens Eye Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Is at least 18 years of age 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;
• Anticipates being able to wear the study lenses for at least 12 hours a day, 7 days a week;
• Is willing and able to follow instructions and maintain the appointment schedule;
• Habitually wears toric soft contact lenses binocularly, of any replacement frequency, for the past 3 months minimum;
• Has refractive astigmatism at least -0.75DC in each eye, maximum -2.25DC;
• Has refractive cylinder axis either between 155 to 25 or between 65 and 115 degrees;
• Is myopic and requires a spectacle spherical component of -1.00D to -6.50D inclusively;
• Can be fit and achieve binocular distance vision of at least 20/30 Snellen with the available lens parameters

Exclusion Criteria:

• Is participating in any concurrent clinical or research study;
• Habitually wears one of the study contact lenses;
• 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: Lens A; daily disposable soft contact lens - test lens Subjects will be randomized to wear test lenses for one week and then cross-over to control lenses for one week.	Device: Lens A; daily disposable soft contact lens - test lens; Device: Lens B; daily disposable soft contact lens - control lens
Active Comparator: Lens B; daily disposable soft contact lens - control lens Subjects will be randomized to wear control lenses for one week and then cross-over to test lenses for one week.	Device: Lens A; daily disposable soft contact lens - test lens; Device: Lens B; daily disposable soft contact lens - control lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Ease of Lens Handling	Ease of overall lens handling for putting on eyes, removing from eyes, and opening packaging will be measured on a 0-10 integer scale (0=Very difficult, 10-Very easy)	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Acuity	Visual acuity will be measured using LogMAR scale in high room illumination high contrast: distance (≥4m)	Baseline - after lenses have settled for 10 minutes
Visual Acuity	Visual acuity will be measured using LogMAR scale in high room illumination high contrast: distance (≥4m)	1 week

Collaborators and Investigators

• Sponsor: CooperVision, Inc.
• Investigators: Study Director: Lyndon Jones, PhD, FCOptom, Centre for Ocular Research and Education

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2021
• Primary Completion (Actual): July 2, 2021
• Study Completion (Actual): July 2, 2021

Study Registration Dates

• First Submitted: April 1, 2021
• First Submitted That Met QC Criteria: April 1, 2021
• First Posted (Actual): April 5, 2021

Study Record Updates

• Last Update Posted (Actual): February 15, 2022
• Last Update Submitted That Met QC Criteria: February 11, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: EX-MKTG-122

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