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OpenTrials
Completed

NCT Number: NCT06046209

Comparing a Monthly Replacement Lens Versus a Daily Disposable Lens

The purpose of this study was to compare subjective ratings of lens handling at insertion for a monthly replacement lens versus a daily disposable lens in habitual soft lens wearers.

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Key information

Age range

17 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Waterloo School of Optometry & Vision Science

Waterloo, Ontario, N2L 3G1, Canada

About this study

This was a non-dispensing, randomized, double-masked, crossover study. Participants wore 2 different contact lenses bilaterally over 4 study visits, all conducted on the same day. Estimated duration of involvement for each participant was 4 hours.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Were 17 to 40 years of age and have full legal capacity to volunteer;
  • Had read and signed an information consent letter;
  • Were willing and able to follow instructions and maintain the appointment schedule;
  • Were habitual daily wearers of spherical single vision soft contact lenses to correct for distance vision in each eye
  • Were correctable to a visual acuity of 20/20 or better (in each eye) with sphero-cylindrical subjective refraction;
  • Had an astigmatism of ≤ 0.75DC in subjective refraction;
  • Could be fit with the study contact lenses with a power between -1.00 and -6.00DS; this translates to best corrected vision sphere refraction that vertexes to a CL power between -1.00 and -6.00 (inclusive) at screening visit.
  • Demonstrated an acceptable fit with the study lenses.

Exclusion criteria

  • Had taken part in another clinical research study within the last 14 days;
  • Were currently habitual wearers of toric, multifocal or monovision lenses.
  • Had worn any rigid contact lenses in the past 6 months
  • Were an extended lens wearer (i.e., sleeping with their lenses)
  • Had a difference of ≥1.5 D in best vision sphere subjective refraction between eyes;
  • Had amblyopia and/or distance strabismus/binocular vision problem;
  • Had any known active ocular disease, allergies and/or infection;
  • Had a systemic condition that in the opinion of the investigator may affect a study outcome variable;
  • Were using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
  • Had a known sensitivity to the diagnostic pharmaceuticals to be used in the study;
  • Had undergone refractive error surgery or intraocular surgery;
  • Were a member of CORE directly involved in the study.

Treatment and study plan

Control lens

Device

Daily disposable contact lens for 90 minutes

Test lens

Device

Monthly replacement contact lens for 90 minutes

Primary outcomes

  1. Lens Handling at Insertion

    Time frame: Immediately after lens application

    Participants completed subjective ratings of the ease of application of the study lenses to eye immediately after lens application on a 0-100 integer scale, where 100=very easy and 0=very difficult.

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Collaborators

  • Centre for Ocular Research & Education, Canada

Registry information

Official study title

Comparing Clariti Elite Versus Proclear 1 Day

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 21, 2023
Registry last updated
Dec 12, 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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