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

August 27, 2026 updated by: CooperVision, Inc.
The aim of this study is to evaluate and compare the performance of two soft contact lenses.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Waterloo, Ontario, Canada, N2L 3G1
        • School of Optometry and Vision Science

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 full legal capacity to volunteer;
  2. Have understood and signed an information consent letter;
  3. Are willing and able to maintain the appointment schedule;
  4. Are an adapted soft contact lens wearer;
  5. Have a vertex-corrected contact lens prescription of -1.00DS to -6.00DS (inclusive) in each eye;
  6. Have a refraction with a cylinder component of no more than -1.00DC in each eye;
  7. 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:

  1. Are participating in any concurrent clinical or research study;
  2. Have any known active ocular disease and/or infection or slit lamp findings that would contraindicate contact lens use;
  3. Have a systemic condition that would contraindicate contact lens use;
  4. Are using any systemic or topical medications that would contraindicate contact lens use;
  5. Have known sensitivity to the diagnostic fluorescein sodium to be used in the study;
  6. Are an employee of the Centre for Ocular Research & Education directly involved in the study (i.e. on the delegation log).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lens 1 (ocufilcon D)
All participants will wear lens 1 for 15 minutes (Period 1).
Device: Lens 1 (ocufilcon D)
15 minutes of daily wear
Experimental: Lens 2 (somofilcon A)
All participants will wear lens 2 for 15 minutes (Period 2).
Device: Lens 2 (somofilcon A)
15 minutes of daily wear

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lens Comfort
Time Frame: Immediately after lens application
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CooperVision, Inc.

Collaborators

Centre for Ocular Research & Education, Canada

Investigators

  • Principal Investigator: Lyndon Jones, PhD FCOptom, Centre for Ocular Research and Education

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 24, 2025

Primary Completion (Actual)

February 25, 2025

Study Completion (Actual)

February 25, 2025

Study Registration Dates

First Submitted

February 5, 2025

First Submitted That Met QC Criteria

February 5, 2025

First Posted (Actual)

February 10, 2025

Study Record Updates

Last Update Posted (Actual)

August 31, 2026

Last Update Submitted That Met QC Criteria

August 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EX-MKTG-164

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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