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Completed

NCT Number: NCT06873048

Short-term Study of Two Soft Contact Lenses in Wearers With Low Astigmatism

The primary objective of the study is to evaluate and compare the performance of two soft contact lens.

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Key information

Age range

17 year–42 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Optometry & Vision Science

Waterloo, Ontario, N2L 3G1, Canada

About this study

The primary objective of the study is to evaluate and compare the performance of two different soft contact lens in existing spherical soft contact lens (CL) wearers with low levels of refractive astigmatism over a 2-week wear period.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • At least 17 years and no more than 42 years of age.
  • Have read and signed the study consent form.
  • Are willing and able to follow instructions and maintain the appointment schedule.
  • Are habitual wearer of spherical soft contact lenses (not toric or multifocal design), any brand and any replacement frequency.
  • Are willing to wear the study contact lenses for 6 days a week while in this study and on three days (day 1, Day 7 and Day 13) for at least 12 hours.
  • Are willing to provide a contact email and telephone number and to use a device that allows them to respond to a short online questionnaire every 3 hours on days 1, 7 and 13 of each lens arm, while wearing one of the 2 study lenses.
  • Are non-presbyopic i.e. no requirement for a reading addition for routine daily tasks (self report).
  • Have astigmatism of either -0.50, -0.75, -1.00 or -1.25 DC in each eye by subjective sphero-cylindrical refraction.
  • Achieves at least 0.10 LogMAR in each eye by subjective sphero-cylindrical refraction.
  • Can be fit with available study contact lens powers of between +6.00 to -10.00 DS.
  • Demonstrate an acceptable fit with the study contact lenses.

Exclusion criteria

  • Are participating in any concurrent clinical interventional study.
  • Have worn rigid contact lenses in the last 3 months.
  • Have worn soft toric contact lenses in the past 3 months.
  • Have any known active ocular disease or allergies and/or infection.
  • Have clinically significant biomicroscopy findings or have an ocular condition that contraindicate contact lens wear.
  • Have a systemic condition that in the opinion of the investigator may affect a study outcome variable or contraindicate wearing soft contact lenses.
  • Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable or contraindicate wearing soft contact lenses.
  • Have known sensitivity to the diagnostic sodium fluorescein to be used in the study.
  • Have undergone refractive error surgery or intraocular surgery.
  • Are an employee of the Centre for Ocular Research & Education directly involved in this study.

Treatment and study plan

Control Contact Lens (stenfilcon A Sphere)

Device

One week of wear

Test Contact Lens (stenfilcon A Toric)

Device

One week of wear

Primary outcomes

  1. Contact Lens Comfort

    Time frame: Day 1 (day after dispense), Day 7 and Day 13 at 12 hours contact lens wear

    Contact lens comfort will be measured on the scale of 0-100 where, (0=worst and 100=best)

Sponsors and collaborators

Lead sponsor

CooperVision International Limited (CVIL)

Industry

Collaborators

  • Centre for Ocular Research & Education, Canada

Registry information

Official study title

Short-term Study of Myday Sphere and Myday Toric Lenses in Existing Spherical Soft Contact Lenses Wearers With Low Astigmatism (Pacific)

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 12, 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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