Phase
Condition
Presbyopia
Treatment
Test Lens (lehfilcon A)
Control Lens (comfilcon A)
Clinical Study ID
Ages > 42 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 aweek;
Were willing and able to follow instructions and maintain the appointment schedule;
Habitually wore spherical multifocal soft contact lenses, for the past 3 monthsminimum:
Maximum of 4 participants (out of 12) per site could be habitual wearers ofdaily disposable lenses,
Maximum of 4 participants (out of 12) per site could be habitual wearers ofBiofinity Multifocal,
Maximum of 4 participants (out of 12) per site could be habitual wearers ofeither 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 whichparticipants also deem to be 'acceptable', with the available study lens parameters (Distance sphere +4 to -6; near addition as per study design).
Exclusion
Exclusion Criteria:
Were participating in any concurrent clinical or research study;
Had any known active ocular disease and/or infection that contraindicated contactlens wear;
Had a systemic or ocular condition that in the opinion of the investigator may haveaffected a study outcome variable;
Were using any systemic or topical medications that in the opinion of theinvestigator 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 ofenrolment;
Had undergone refractive error surgery or intraocular surgery.
Study Design
Study Description
Connect with a study center
Spadina Optometry
Toronto, Ontario M5V 3E7
CanadaSite Not Available
Complete Eye Care of Medina
Medina, Minnesota 55364
United StatesSite Not Available
Sacco Eye Group
Vestal, New York 13850
United StatesSite Not Available
ProCare Vision Center
Granville, Ohio 43023
United StatesSite Not Available
New Bremen EyeCare
New Bremen, Ohio 45869
United StatesSite Not Available
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