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OpenTrials
Completed

NCT Number: NCT05805059

Performance Evaluation of Different Daily Disposable Silicone Hydrogel Contact Lenses

The goal of this study is to compare the performance of two daily disposable silicone hydrogel contact lenses.

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Insight Eye Care, Waterloo, Ontario, Canada

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About this study

This study is a prospective, bilateral eye, double masked, randomized, 1-week crossover, daily wear design involving two different daily disposable lens types. Each lens type will be worn for approximately one week.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Is between 18 and 35 years of age (inclusively) and has full legal capacity to volunteer;
  • Has read and signed an information consent letter;
  • Self-reports having a full eye examination in the previous two years;
  • Anticipates being able to wear the study lenses for at least 8 hours a day, 7 days a week;
  • Is willing and able to follow instructions and maintain the appointment schedule;
  • Habitually wears soft contact lenses, for the past 3 months minimum;
  • No more than 1/3 of participants should be habitual wearer of MyDay or MyDay Energys
  • No more than 1/3 of participants should be habitual wearer of ACUVUE® OASYS MAX 1-Day or ACUVUE® OASYS 1-Day.
  • Has refractive astigmatism no higher than -0.75DC in each eye;
  • Can be fit and achieve binocular distance vision of at least 20/30 Snellen (Available lens parameters are sphere -1.00 to -6.00D, 0.25D steps).

Exclusion criteria

  • Is participating in any concurrent clinical or research study;
  • Has any known active ocular disease and/or infection that contraindicates contact lens wear;
  • Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
  • Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable;
  • Has known sensitivity to the diagnostic sodium fluorescein used in the study;
  • Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;
  • Has undergone refractive error surgery or intraocular surgery.

Treatment and study plan

Control Contact Lens (stenfilcon A)

Device

one week wear

Test Contact Lens (senofilcon A)

Device

one week of wear

Primary outcomes

  1. Lens Handling on Removal

    Time frame: Collected once on day 6 at the end of wear

    Lens Handling on Removal, using a 0-100 scale (0=Very difficult, 100=Very easy)

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Collaborators

  • Centre for Ocular Research & Education, Canada

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 7, 2023
Registry last updated
Sep 26, 2024

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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