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OpenTrials
Completed

NCT Number: NCT06431061

Clinical Evaluation of Proclear Toric and Biofinity Toric

The aim of this study is to compare the short-term clinical performance of two Toric contact lenses.

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Key information

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Waterloo

Waterloo, Canada

About this study

The aim of the study is to evaluate and compare the performance of two soft toric contact lenses in existing soft toric lens wearers in a short term (15 minutes wear) study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Are at least 17 years of age and has full legal capacity to volunteer.
  • Have understood and signed an information consent letter.
  • Are willing and able to follow instructions and maintain the appointment schedule.
  • Are an adapted soft toric contact lens wearer.
  • Do not habitually wear either of the two study lens types.
  • Have a vertex-corrected contact lens prescription with a spherical component of +4.00D to -9.00D in combination with astigmatism of no less than -0.75D and no more than -2.25D in each eye.
  • Can achieve best corrected distance visual acuity of +0.10 logMAR (subjective refraction) or better in each eye.
  • Can be fitted with and achieve a distance visual acuity of +0.18 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 in the opinion of the investigator may affect a study outcome variable.
  • Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable.
  • Have known sensitivity to the diagnostic pharmaceuticals to be used in the study.
  • Have a history of not achieving comfortable CL use (5 days per week; > 8 hours/day)
  • 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 A (omafilcon B)

Device

15 minutes of daily wear.

Lens B (comfilcon A)

Device

15 minutes of daily wear.

Primary outcomes

  1. Overall Fit Acceptance

    Time frame: After 15 minutes of continuous wear

    Overall fit acceptance will be measured on scale of (0-4) where (0=Should not be worn and 4=Perfect)

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Collaborators

  • Centre for Ocular Research & Education, Canada

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 28, 2024
Registry last updated
Sep 15, 2025

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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