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OpenTrials
Completed

NCT Number: NCT05333965

To Evaluate The Performance Of Two Monthly Replacement Silicone Hydrogel Contact Lenses After 1-month Of Wear

To evaluate the performance of two monthly replacement silicone hydrogel contact lenses in habitual FRP CL wearers when worn for 1-month.

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Key information

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Optometry & Vision Science

Waterloo, N2L 3G1, Canada

About this study

This study will be a prospective, randomized, double-masked, single-site, 1-month cross-over design involving bilateral eye daily wear of two different monthly replacement CL types. Each lens will be worn bilaterally for approximately one month.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Is at least 17 years of age and has full legal capacity to volunteer;
  • Self-reports having had a full eye examination within the previous 2 years;
  • Has read and signed an information consent letter;
  • Is willing and able to follow instructions and maintain the appointment schedule;
  • Is a habitual wearer of frequent replacement contact lenses;
  • Anticipates no difficulty wearing the contact lenses for 6 days/week and 8 hours/day during the study;
  • Has refractive astigmatism no higher than -0.75DC in each eye;
  • Can be successfully fit with both study lens types;
  • Achieves at least 0.4 logMAR VA monocularly and at least 0.2 logMAR VA binocularly with each study lens type.

Exclusion criteria

  • Is participating in any concurrent clinical research study;
  • Has any known active ocular disease and/or infection;
  • Has an unstable systemic condition that in the opinion of the investigator may affect vision or contact lens comfort across the 2-month study duration;
  • Is using any systemic or topical medications in an irregular routine that in the opinion of the investigator may affect vision or contact lens comfort across the 2-month study duration;
  • Has known sensitivity to the diagnostic sodium fluorescein to be used in the study;
  • Is an employee of the Centre for Ocular Research & Education.

Treatment and study plan

Lens A (lehfilcon A lens)

Device

Daily wear for 1 month.

Lens B (comfilcon A lens)

Device

Daily wear for 1 month.

Primary outcomes

  1. Lens Handling on Lens Removal

    Time frame: 1 month

    Lens handling on removal will be measured on a scale of 0-10, 0.5 steps (0=Completely dissatisfied,10=Completely satisfied)

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 19, 2022
Registry last updated
Oct 23, 2023

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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