Performance Evaluation of Different Daily Disposable Silicone Hydrogel Contact Lenses

CooperVision

Status: Completed

Conditions: Myopia

Treatments: Device: Control Contact Lens (stenfilcon A); Device: Test Contact Lens (senofilcon A)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05805059

EX-MKTG-145

Details and patient eligibility

About

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

Full 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.

Enrollment: 68 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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68 participants in 2 patient groups

Control Contact Lens, Then Test Contact Lens

Experimental group

Description:

Participants will wear control contact lenses for one week and then crossover to test contact lenses for one week.

Treatment:

Device: Test Contact Lens (senofilcon A)

Device: Control Contact Lens (stenfilcon A)

Test Contact Lens, Then Control Contact Lens

Experimental group

Description:

Participants will wear test contact lenses for one week and then crossover to control contact lenses for one week.

Treatment:

Device: Test Contact Lens (senofilcon A)

Device: Control Contact Lens (stenfilcon A)