Clinical Investigation of Proclear® 1 Day and MyDay® Sphere Contact Lenses

CooperVision International Limited (CVIL)

Status: Active, not recruiting

Conditions: Myopia; Ametropia

Treatments: Device: Control Lens (omafilcon A); Device: Test Lens (stenfilcon A)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07104773

EX-MKTG-169

Details and patient eligibility

About

The aim of this study is to evaluate and compare the performance of two soft contact lenses.

Full description

The aim of this study is to evaluate and compare the performance of a hydrogel lens and a silicone hydrogel lens in existing soft lens wearers.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Are at least 18 years of age and have capacity to consent;
2. Have understood and signed an information consent form;
3. Are an adapted soft contact lens wearer (worn for at least 3 months);
4. Have a contact lens prescription of -1.00DS to -6.00DS (inclusive) in each eye;
5. Have a refraction with a cylinder component of no more than -0.75DC in each eye;
6. Can achieve a best spectacle-corrected visual acuity in each eye of +0.10 logMAR or better.

Exclusion criteria

1. Participation in a contact lens or contact lens care product clinical trial in the previous 30 days;
2. Have any known active anterior segment disease and/or infection or slit lamp findings that would contraindicate contact lens wear;
3. Have a systemic condition that would contraindicate contact lens wear;
4. Are using any systemic or topical medications that would contraindicate contact lens wear;
5. Have known sensitivity to the diagnostic fluorescein sodium to be used in the study;
6. Are an employee of the study site (Centre for Ocular Research & Education) and directly involved in the study (ie. on the delegation log).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Control Lens (omafilcon A)

Experimental group

Description:

All participants will wear Control Lens for 15 minutes (Period 1).

Treatment:

Device: Control Lens (omafilcon A)

Test Lens (stenfilcon A)

Experimental group

Description:

All participants will wear Test Lens for 15 minutes (Period 2).

Treatment:

Device: Test Lens (stenfilcon A)