Soft Lens Study: Biomedics 1 Day Extra Sphere and Clariti... | NCT06817785

Studies
Soft Lens Study: Biomedics 1 Day Extra Sphere and Clariti 1 Day Sphere

NCT06817785

Sponsor

CooperVision, Inc.

Status

Completed

Last Update Posted

Apr 8, 2026Actual

Enrollment

45Actual

Phase

Not Applicable

Conditions

Myopia

Interventions

Lens 1 (ocufilcon D)
Lens 2 (somofilcon 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

Jan 24, 2025Actual

Primary Completion Date

Feb 25, 2025Actual

Completion Date

Feb 25, 2025Actual

First Submitted Date

Feb 5, 2025

First Submission Date that Met QC Criteria

Feb 5, 2025

First Posted Date

Feb 10, 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 myopic 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

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lens 1 (ocufilcon D)	Experimental	All participants will wear lens 1 for 15 minutes (Period 1).	Device: Lens 1 (ocufilcon D)
Lens 2 (somofilcon A)	Experimental	All participants will wear lens 2 for 15 minutes (Period 2).	Device: Lens 2 (somofilcon A)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lens 1 (ocufilcon D)	Device	15 minutes of daily wear	Lens 1 (ocufilcon D)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Lens Comfort	The primary outcome of this study is lens comfort immediately after lens application on a scale of 0-100 (0= worst, 100=best).	Immediately after lens application

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Are at least 18 years of age and have full legal capacity to volunteer;
Have understood and signed an information consent letter;
Are willing and able to maintain the appointment schedule;
Are an adapted soft contact lens wearer;
Have a vertex-corrected contact lens prescription of -1.00DS to -6.00DS (inclusive) in each eye;
Have a refraction with a cylinder component of no more than -1.00DC in each eye;
Can be fitted with and achieve a distance visual acuity of +0.10 logMAR or better in each eye with the study contact lenses.

Exclusion Criteria:

Are participating in any concurrent clinical or research study;
Have any known active ocular disease and/or infection or slit lamp findings that would contraindicate contact lens use;
Have a systemic condition that would contraindicate contact lens use;
Are using any systemic or topical medications that would contraindicate contact lens use;
Have known sensitivity to the diagnostic fluorescein sodium to be used in the study;
Are an employee of the Centre for Ocular Research & Education directly involved in the study (i.e. 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
Lyndon Jones, PhD FCOptom	Centre for Ocular Research and Education	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
School of Optometry and Vision Science		Waterloo	Ontario	N2L 3G1	Canada

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases