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

Astigmatism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04831515
• Other study ID #: EX-MKTG-122
• Status: Completed
• Phase: N/A
• Start date: March 29, 2021
• Est. completion date: July 2, 2021

Study information

• Verified date: February 2022
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 2, 2021
• Est. primary completion date: July 2, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Astigmatism

Intervention

Device:
• Lens A
daily disposable soft contact lens - test lens
• Lens B
daily disposable soft contact lens - control lens

Locations

Country	Name	City	State
United States	Athens Eye Care	Athens	Ohio
United States	Golden Vision	Sarasota	Florida
United States	Sacco Eye Group	Vestal	New York
United States	Golden Optometric Group	Whittier	California

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Visual Acuity	Visual acuity will be measured using LogMAR scale in high room illumination high contrast: distance (=4m)	1 week