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

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

Study Overview

• Status: Completed
• Conditions: Myopia; Ametropia
• Intervention / Treatment: Device: Control Lens (omafilcon A); Device: Test Lens (stenfilcon A)

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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2L 3G1
      • Centre for Ocular Research & Education

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Control Lens (omafilcon A); All participants will wear Control Lens for 15 minutes (Period 1).	Device: Control Lens (omafilcon A); 15 minutes of daily wear
Experimental: Test Lens (stenfilcon A); All participants will wear Test Lens for 15 minutes (Period 2).	Device: Test Lens (stenfilcon A); 15 minutes of daily wear

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: CooperVision International Limited (CVIL)
• Collaborators: Centre for Ocular Research & Education, Canada
• Investigators: Principal Investigator: Jill Woods, MSc, MCOptom, Centre of Ocular Research and Education

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2025
• Primary Completion (Actual): August 21, 2025
• Study Completion (Actual): August 21, 2025

Study Registration Dates

• First Submitted: July 29, 2025
• First Submitted That Met QC Criteria: July 29, 2025
• First Posted (Actual): August 5, 2025

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Myopia; Refractive Errors
• Other Study ID Numbers: EX-MKTG-169

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes