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OpenTrials
Completed

NCT Number: NCT04831515

Performance Evaluation of Two Daily Disposable Toric Lens Designs in Habitual Soft Contact Lens Wearers

The objective of the study is to compare the clinical performance of two different daily disposable, SiHy toric contact lens types, Lens A and Lens B, in existing soft lens wearers when worn for one week each.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Golden Optometric Group, Whittier, California, United States

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About this study

This study is a prospective, bilateral eye, double-masked, randomized, 1-week cross-over, daily-wear design involving two different daily disposable toric lens types. Each lens type will be worn for approximately one week, during which participants record their subjective lens-wear experience.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Is at least 18 years of age 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 12 hours a day, 7 days a week;
  • Is willing and able to follow instructions and maintain the appointment schedule;
  • Habitually wears toric soft contact lenses binocularly, of any replacement frequency, for the past 3 months minimum;
  • Has refractive astigmatism at least -0.75DC in each eye, maximum -2.25DC;
  • Has refractive cylinder axis either between 155 to 25 or between 65 and 115 degrees;
  • Is myopic and requires a spectacle spherical component of -1.00D to -6.50D inclusively;
  • Can be fit and achieve binocular distance vision of at least 20/30 Snellen with the available lens parameters

Exclusion criteria

  • Is participating in any concurrent clinical or research study;
  • Habitually wears one of the study contact lenses;
  • 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

Lens A

Device

daily disposable soft contact lens - test lens

Lens B

Device

daily disposable soft contact lens - control lens

Primary outcomes

  1. Overall Ease of Lens Handling

    Time frame: 1 week

    Ease of overall lens handling for putting on eyes, removing from eyes, and opening packaging will be measured on a 0-10 integer scale (0=Very difficult, 10-Very easy)

Secondary outcomes

  1. Visual Acuity

    Time frame: Baseline - after lenses have settled for 10 minutes

    Visual acuity will be measured using LogMAR scale in high room illumination high contrast: distance (≥4m)

  2. Visual Acuity

    Time frame: 1 week

    Visual acuity will be measured using LogMAR scale in high room illumination high contrast: distance (≥4m)

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 5, 2021
Registry last updated
Feb 15, 2022

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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