N/A
N=60
Evaluating Two Multifocal Daily Disposable Contact Lenses
Presbyopia
Bottom Line
View on ClinicalTrials.gov: NCT05579886 ↗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
| Outcome | Result | p-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.
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.