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

NCT ID: NCT07104773

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-25
• Study Completion Date: 2025-08-31

Brief Summary

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

Detailed 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.

Conditions

Ametropia; Myopia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control Lens (omafilcon A)

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

Group Type: EXPERIMENTAL

Control Lens (omafilcon A)

Intervention Type: DEVICE

15 minutes of daily wear

Test Lens (stenfilcon A)

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

Group Type: EXPERIMENTAL

Test Lens (stenfilcon A)

Intervention Type: DEVICE

15 minutes of daily wear

Interventions

Control Lens (omafilcon A)

15 minutes of daily wear

Intervention Type: DEVICE

Test Lens (stenfilcon A)

15 minutes of daily wear

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre for Ocular Research & Education, Canada

OTHER

Sponsor Role: collaborator

CooperVision International Limited (CVIL)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jill Woods, MSc, MCOptom

Role: PRINCIPAL_INVESTIGATOR

Centre of Ocular Research and Education

Locations

Centre for Ocular Research & Education

Waterloo, Ontario, Canada

Countries

Canada

Other Identifiers

EX-MKTG-169

Identifier Type: -

Identifier Source: org_study_id