Performance Evaluation of Different Daily Disposable Silicone Hydrogel Contact Lenses.

Myopia Clinical Trial

Official title:

Performance Evaluation of Different Daily Disposable Silicone Hydrogel Contact Lenses.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05805059
• Other study ID #: EX-MKTG-145
• Status: Completed
• Phase: N/A
• Start date: April 14, 2023
• Est. completion date: June 20, 2023

Study information

• Verified date: March 2023
• Source: Coopervision, Inc.
• Contact: n/a
• 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 contact lenses.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 20, 2023
• Est. primary completion date: June 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myopia

Intervention

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

Locations

Country	Name	City	State
Canada	Insite Eye Care	Waterloo	Ontario
United States	Procare Vision	Granville	Ohio
United States	Coan Eye Care & Optical Boutique	Ocoee	Florida
United States	Sacco Eye Group	Vestal	New York

Sponsors (2)

Lead Sponsor	Collaborator
Coopervision, Inc.	CORE

Countries where clinical trial is conducted

United States,  Canada, 

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