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

NCT07104773 | Completed FDA Device

• 1 other identifier: EX-MKTG-169
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ametropia; Myopia

Outcome Measures

Primary Outcomes (1)

• Subjective Comfort Rating

  The primary outcome of this study is lens comfort on a scale of 0-100 (0= worst, 100=best).

  At the end of 15 minutes of daily wear

Study Arms (2)

Control Lens (omafilcon A)

EXPERIMENTAL

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

Device: Control Lens (omafilcon A)

Test Lens (stenfilcon A)

EXPERIMENTAL

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

Device: Test Lens (stenfilcon A)

Interventions

Control Lens (omafilcon A) DEVICE

15 minutes of daily wear

Control Lens (omafilcon A)

Test Lens (stenfilcon A) DEVICE

15 minutes of daily wear

Test Lens (stenfilcon A)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• CooperVision International Limited (CVIL): lead
• Centre for Ocular Research & Education, Canada: collaborator

Study Sites (1)

Centre for Ocular Research & Education

Waterloo, Ontario, N2L 3G1, Canada

Location

MeSH Terms

Conditions

Refractive Errors; Myopia

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Jill Woods, MSc, MCOptom

  Centre of Ocular Research and Education

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 5, 2025
• Study Start: July 24, 2025
• Primary Completion: August 21, 2025
• Study Completion: August 21, 2025
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

CA (1)