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OpenTrials
Completed

NCT Number: NCT06817785

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Optometry and Vision Science

Waterloo, Ontario, N2L 3G1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Lens 1 (ocufilcon D)

Device

15 minutes of daily wear

Lens 2 (somofilcon A)

Device

15 minutes of daily wear

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Collaborators

  • Centre for Ocular Research & Education, Canada

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 10, 2025
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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