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

NCT06817785 | Completed FDA Device

• 1 other identifier: EX-MKTG-164
• Study Type: interventional
• Target: 45
• 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

Myopia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Lens 1 (ocufilcon D) DEVICE

15 minutes of daily wear

Lens 1 (ocufilcon D)

Lens 2 (somofilcon A) DEVICE

15 minutes of daily wear

Lens 2 (somofilcon 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 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Centre for Ocular Research & Education, Canada: collaborator
• CooperVision, Inc.: lead

Study Sites (1)

School of Optometry and Vision Science

Waterloo, Ontario, N2L 3G1, Canada

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Lyndon Jones, PhD FCOptom

  Centre for 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: February 5, 2025
• First Posted: February 10, 2025
• Study Start: January 24, 2025
• Primary Completion: February 25, 2025
• Study Completion: February 25, 2025
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

CA (1)