Evaluating Two Multifocal Daily Disposable Contact Lenses
Completed · Not applicable
Conditions studied: Presbyopia
In brief
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.
Key facts
- Study ID
- NCT05579886
- Run by
- CooperVision, Inc.
- People needed
- 60
- Starts
- 2022-10-10
- Expected to finish
- 2023-02-07
- Last updated by the study team
- 2024-02-20
Who can join
Age: 42 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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.
Where it is running
- Coan Eye Care & Optical Boutique — Ocoee, Florida, United States
- Kannarr Eye Care — Pittsburg, Kansas, United States
- Sacco Eye Group — Vestal, New York, United States
- ProCare Vision Center — Granville, Ohio, United States
- Nittany Eye Associates — State College, Pennsylvania, United States
Full record on ClinicalTrials.gov
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