Evaluation of the Performance of Different Daily Disposable Lens Designs in Habitual Soft Contact Lens Wearers

Myopia Clinical Trial

Official title:

Evaluation of the Performance of Different Daily Disposable Lens Designs in Habitual Soft Contact Lens Wearers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04668989
• Other study ID #: EX-MKTG-118
• Status: Completed
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: February 5, 2021

Study information

• Verified date: September 2021
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objective of the study is to refit existing soft lens wearers with two different daily disposable contact lens types, Lens A and Lens B, to determine their performance after one week of wear.

Description:

This study is a prospective, bilateral eye, double-masked, randomized, 1-week cross-over, daily-wear design involving two different daily disposable 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: 68
• Est. completion date: February 5, 2021
• Est. primary completion date: February 5, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Is at least 18 years of age 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;

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. Habitually wears one of the study contact lenses;

3. Has any known active* ocular disease and/or infection that contraindicates contact lens wear;

4. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;

5. Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable;

6. Has known sensitivity to the diagnostic sodium fluorescein used in the study;

7. Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;

8. Has undergone refractive error surgery or intraocular surgery.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• stenfilcon A - (Test lens)
Subjects will be randomized to wear test lenses for one week.
• kalifilcon A - (Control Lens)
Subjects will be randomized to wear control lenses for one week.

Locations

Country	Name	City	State
United States	Athens Eye Care	Athens	Ohio
United States	Nittany Eye Associates	College	Pennsylvania
United States	Complete Eye Care of Medina	Medina	Minnesota
United States	Sacco Eye Group, PLLC	Vestal	New York

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lens Wettability	Lens wettability on a 0 to 4 descriptive scale, 0.5 steps (0 - Very poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 - Poor: Irregular surface appearance, drying time << blink time, 2 - Acceptable: Smooth surface appearance immediately after the blink becoming irregular after a while, drying time = blink time, 3 - Good: Typical soft lens appearance with long drying time, 4 - Excellent: Appearance similar to a healthy cornea with very long drying time)	Baseline - after 2 hours of lens wear
Primary	Lens Wettability	Lens wettability on a 0 to 4 descriptive scale, 0.5 steps (0 - Very poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 - Poor: Irregular surface appearance, drying time << blink time, 2 - Acceptable: Smooth surface appearance immediately after the blink becoming irregular after a while, drying time = blink time, 3 - Good: Typical soft lens appearance with long drying time, 4 - Excellent: Appearance similar to a healthy cornea with very long drying time)	1 week