Skip to main content
OpenTrials
Completed

NCT Number: NCT06098339

Performance Evaluation of Reusable Contact Lenses When Worn For One Month By Habitual Soft Contact Lens Wearers

The purpose of this study was to compare the clinical performance of two different reusable lenses in habitual spherical soft lens wearers.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Insight Eye Care, Waterloo, Ontario, Canada

Loading trial locations.

About this study

This study was a prospective, bilateral eye, double-masked, randomized, 1 month cross-over, daily-wear design involving two different frequent replacement type lenses. Duration of involvement for each participant was approximately 3 months.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Were at least 18 years of age and no older than 39 years, and had 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;
  • Self-reported having had a full eye examination in the previous two years;
  • Had healthy eyes with no health condition or medication that contra-indicate contact lens wear, in the opinion of the investigator;
  • Anticipated being able to wear the study lenses for at least 8 hours a day, 6 days a week;
  • Habitually wore spherical soft contact lenses, for the past 3 months minimum:

It was preferred that all participants were habitual frequent replacement lens wearers. However, if this was not possible then no more than 5 participants could be habitual daily disposable lens wearers at each site, the rest had to be habitual frequent replacement lens wearers;

  • For the frequent replacement wearers: No more than 3 could be habitual wearers of the Avaira Vitality™/ Serenity™ brand (or their equivalent private label brand name) and no more than 3 could be habitual wearers of AIR OPTIX® plus HydraGlyde® can be enrolled at each site;
  • Had refractive astigmatism no higher than -0.75DC in each eye;
  • Could be fit and achieve binocular distance vision of at least 20/30 Snellen (Available lens parameters are sphere +6.00 to -6.00D, 0.25D steps).

Exclusion criteria

  • 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 or ocular 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 affect contact lens wear or a study outcome variable;
  • Had known sensitivity to the diagnostic sodium fluorescein used in the study;
  • Self-reported as pregnant, lactating or planning a pregnancy at the time of enrolment;
  • Had undergone refractive error surgery or intraocular surgery.

Treatment and study plan

Lens A (fanfilcon A)

Device

Daily wear for one month

Lens B (lotrafilcon B)

Device

Daily wear for one month

Primary outcomes

  1. Lens Handling on Removal

    Time frame: Day 27

    Participants measured subjective lens handling at removal on a 0-100 integer scale, where 0=worst and 100=best. Results for each lens were collected in the at-home diary on Day 27.

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Collaborators

  • Centre for Ocular Research & Education, Canada

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 24, 2023
Registry last updated
Aug 28, 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.