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N/A N=60 Treatment

Evaluating Two Multifocal Daily Disposable Contact Lenses

Presbyopia

Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: Comfort Just After Lens Insertion — 9.1; 9.2 score on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Control Lens (Device); Test Lens (Device)
Age
Adult, Older Adult · 42+ yrs
Sex
All
Sponsor
CooperVision, Inc.
Primary completion
Feb 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Comfort Just After Lens Insertion
9.1; 9.2

Summary

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.

Eligibility Criteria

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05579886). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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