Performance Evaluation of Different Daily Disposable Silicone Hydrogel Contact Lenses.

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: Control Contact Lens (stenfilcon A); Device: Test Contact Lens (senofilcon A)

• Registration Number: NCT05805059
• Lead Sponsor: Coopervision, Inc.

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2023-03
• Study First Submitted: 2023-03-28
• Study First Submitted QC: 2023-03-28
• Study First Posted: 2023-04-07
• Study Start: 2023-04-14
• Primary Completion: 2023-06-20
• Study Completion: 2023-06-20
• Last Update Submitted: 2023-12-06
• Last Update Posted: 2023-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control Contact Lens, Then Test Contact Lens	Control Contact Lens (stenfilcon A)	Participants will wear control contact lenses for one week and then crossover to test contact lenses for one week.
Test Contact Lens, Then Control Contact Lens	Control Contact Lens (stenfilcon A)	Participants will wear test contact lenses for one week and then crossover to control contact lenses for one week.
Control Contact Lens, Then Test Contact Lens	Test Contact Lens (senofilcon A)	Participants will wear control contact lenses for one week and then crossover to test contact lenses for one week.
Test Contact Lens, Then Control Contact Lens	Test Contact Lens (senofilcon A)	Participants will wear test contact lenses for one week and then crossover to control contact lenses for one week.

Primary Outcome Measures

Name	Time	Method
Lens Handling on Removal	Collected once on day 6 at the end of wear	Lens Handling on Removal, using a 0-100 scale (0=Very difficult, 100=Very easy)

Trial Locations

Locations (4)

Coan Eye Care; 🇺🇸 Ocoee, Florida, United States

Sacco Eye Group, PLLC; 🇺🇸 Vestal, New York, United States

ProCare Vision Center; 🇺🇸 Granville, Ohio, United States

Insight Eye Care; 🇨🇦 Waterloo, Ontario, Canada