Performance Comparison of Two Monthly Replacement Silicone Hydrogel Multifocal Lens Types
Completed · Not applicable
Conditions studied: Presbyopia
In brief
To evaluate and compare the performance of two monthly replacement multifocal contact lenses in existing wearers.
Key facts
- Study ID
- NCT06232590
- Run by
- CooperVision International Limited (CVIL)
- People needed
- 60
- Starts
- 2024-02-23
- Expected to finish
- 2024-07-09
- Last updated by the study team
- 2025-02-12
Who can join
Age: 42 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Were 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;
- Were willing and able to follow instructions and maintain the appointment schedule;
- Habitually wore spherical multifocal soft contact lenses, for the past 3 months minimum:
- Maximum of 4 participants (out of 12) per site could be habitual wearers of daily disposable lenses,
- Maximum of 4 participants (out of 12) per site could be habitual wearers of Biofinity Multifocal,
- Maximum of 4 participants (out of 12) per site could be habitual wearers of either TOTAL30 Multifocal or AirOptix plus HydraGlyde Multifocal
- Had refractive astigmatism no higher than -0.75DC;
- Is presbyopic and requires a reading addition of at least +0.75D and no more than +2.50D;
- Could be fit and achieve binocular distance vision of at least 20/30 Snellen which participants also deem to be 'acceptable', with the available study lens parameters (Distance sphere +4 to -6; near addition as per study design).
You may not qualify if…
- 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.
Where it is running
- Complete Eye Care of Medina — Medina, Minnesota, United States
- Sacco Eye Group — Vestal, New York, United States
- ProCare Vision Center — Granville, Ohio, United States
- New Bremen EyeCare — New Bremen, Ohio, United States
- Spadina Optometry — Toronto, Ontario, Canada
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.