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OpenTrials
Completed

NCT Number: NCT05579886

Evaluating Two Multifocal Daily Disposable Contact Lenses

The objective of the study was to adapt existing multifocal soft lens wearers to a Control Lens for at least 2 weeks and then evaluate the success of switching them to the Test Lens, with a review after 2 weeks.

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Key information

Age range

42 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Coan Eye Care & Optical Boutique, Ocoee, Florida, United States

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About this study

This prospective, bilateral eye, open label, non-randomized study compared the performance of 2 different designs of daily disposable multifocal contact lenses.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

A person was eligible for inclusion in the study if he/she:

  • Was 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;
  • Was willing and able to follow instructions and maintain the appointment schedule;
  • Habitually wore multifocal soft contact lenses, for the past 3 months minimum (NOTE: the habitual contact lens type was restricted such that no more than one third were to be the clariti 1 day multifocal and no more than one third were to be MyDay multifocal (this included their equivalent private label brand name);
  • Had refractive astigmatism no higher than -0.75DC in each eye;
  • Was presbyopic and required a reading addition of at least +0.75D and no more than +2.50D in each eye;
  • 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)

Exclusion criteria

A person was excluded from the study if he/she:

  • Was 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;
  • Was 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

Device

Daily disposable multifocal soft lens with 2 add design (2ADD) for 2 weeks

Test lens

Device

Daily disposable multifocal soft lens with 3 add design (3ADD) for 2 weeks

Primary outcomes

  1. Comfort Just After Lens Insertion

    Time frame: 2 weeks

    Subjective rating measured on a scale of 0-10, 0.5 steps, where 0=Painful, 10=Can't feel the lenses.

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Collaborators

  • Centre for Ocular Research & Education, Canada

Registry information

Official study title

Evaluating the Success of Refitting Lens Wearers With MyDay Multifocal, Who Are Already Adapted to Clariti 1Day Multifocal 2-Add Design

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 14, 2022
Registry last updated
Feb 20, 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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