Clinical Investigation of Proclear® 1 Day and MyDay® Sphe... | NCT07104773

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

NCT07104773

Sponsor

CooperVision International Limited (CVIL)

Status

Completed

Last Update Posted

Apr 8, 2026Actual

Enrollment

44Actual

Phase

Not Applicable

Conditions

Ametropia
Myopia

Interventions

Control Lens (omafilcon A)
Test Lens (stenfilcon A)

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 24, 2025Actual

Primary Completion Date

Aug 21, 2025Actual

Completion Date

Aug 21, 2025Actual

First Submitted Date

Jul 29, 2025

First Submission Date that Met QC Criteria

Jul 29, 2025

First Posted Date

Aug 5, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 6, 2026

Last Update Posted Date

Apr 8, 2026Actual

Name	Class
Centre for Ocular Research & Education, Canada	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

44Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Control Lens (omafilcon A)	Device	15 minutes of daily wear	Control Lens (omafilcon A)

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jill Woods, MSc, MCOptom	Centre of Ocular Research and Education	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre for Ocular Research & Education		Waterloo	Ontario	N2L 3G1	Canada

ID	Term
D012030	Refractive Errors
D009216	Myopia