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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05805150
• Other study ID #: EX-MKTG-148
• Status: Recruiting
• Phase: N/A
• Start date: February 28, 2023
• Est. completion date: July 31, 2023

Study information

• Verified date: March 2023
• Source: Coopervision, Inc.
• Contact: Jose A Vega, OD,MSc,FAAO
• Phone: 9256213761
• Email: javega[@]coopervision.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 73
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Control Contact Lens (stenfilcon A)
One week wear
• Test Contact Lens (senofilcon A)
One week wear

Locations

Country	Name	City	State
United States	Complete Eye Care of Medina/Complete Vision Solutions	Medina	Minnesota
United States	Kannarr Eye Care	Pittsburg	Kansas
United States	Nittany Eye Associate	State College	Pennsylvania
United States	West Bay Associate	Warwick	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Coopervision, Inc.	CORE

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lens Handling on Removal	Lens Handling on Removal using a 0-100 scale (0= very difficult, 100= very easy)	6 days of wear