Skip to main content
OpenTrials
Completed

NCT Number: NCT05763628

Performance Evaluation of Different Daily Disposable Multifocal Contact Lenses

The objective of the study was to compare the lens performance of two daily disposable multifocal contact lenses.

Completed

Looking for future studies?

Notify Me

Key information

Age range

42 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eyes on Sheppard Clinic, Toronto, Ontario, Canada

Loading trial locations.

About this study

This was a prospective, randomized, participant-masked, crossover, bilateral dispensing study. Each lens type was worn for approximately 3-4 weeks: the lens prescription of each lens type was optimized after a 3-8 days wearing experience, then participants began a 2 week (14-21 day) wear period.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Were at least 42 years of age and had full legal capacity to volunteer;
  • Had read and signed an information consent letter;
  • Self-reported having had a full eye examination in the previous two years;
  • Anticipated being able to wear the study lenses for at least 8 hours a day, 5 days a week
  • Were willing and able to follow instructions and maintain the appointment schedule;
  • Habitually wore multifocal soft contact lenses, for the past 3 months minimum
  • Maximum of 7 participants per site were habitual wearers of daily disposable lenses
  • Maximum of 3 habitual wearers per site of 1-Day Acuvue Moist Multifocal
  • Maximum of 1 habitual wearer per site of ACUVUE OASYS MAX 1-Day MULTIFOCAL
  • Maximum of 3 habitual wearers per site of MyDay Multifocal
  • Maximum of 7 participants per site were habitual wearers of frequent replacement lenses
  • Maximum of 1 habitual wearer per site of ACUVUE OASYS for PRESBYOPIA
  • Had refractive astigmatism no higher than -0.75DC in each eye;
  • Were presbyopic and required a reading addition of at least +0.75D and no more than +2.50D;
  • Could be fit and achieved binocular distance vision of at least 20/30 Snellen (or +0.20 logMAR) which participants also deemed to be 'acceptable', with the available study lens parameters (powers +4.00 to -6.00DS, near addition as per study design)

Exclusion criteria

A person was excluded from the study if they:

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

Treatment and study plan

Control Lens (stenfilcon A)

Device

Daily Disposable Multifocal Contact Lens for 2 weeks

Test Lens (senofilcon A)

Device

Daily Disposable Multifocal Contact Lens for 2 weeks

Primary outcomes

  1. Lens Handling for Removal

    Time frame: 2 Weeks

    Subjective rating for ease of removal of the study lenses on a 0-100 scale, where 0=Very difficult and 100=Very easy. Collected once at the end of 2 weeks of wear.

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Collaborators

  • Centre for Ocular Research & Education, Canada

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 10, 2023
Registry last updated
Jul 8, 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.

Published trials that share one or more normalized conditions with this study.