Performance Evaluation of Different Daily Disposable Silicone Hydrogel Contact Lenses.

Not Applicable

Completed

• Conditions: Myopia

• 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

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