Bilateral Dispensing Study of Fanfilcon A Toric Versus Enfilcon A Toric Lenses

Completed · Not applicable

Conditions studied: Myopia, Hyperopia, Astigmatism

In brief

Bilateral dispensing clinical trial of fanfilcon A toric lens verses enfilcon A toric lens over two weeks.

Key facts

Study ID

NCT02423109

Run by

CooperVision, Inc.

People needed

44

Starts

2015-09-01

Expected to finish

2016-03-01

Last updated by the study team

2018-01-10

Who can join

Age: 17 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Are at least 17 years of age for Canada and 18 years of age for the USA and have full legal capacity to volunteer;
• Have read and signed an information consent letter;
• Are willing and able to follow instructions and maintain the appointment schedule;
• Are an adapted soft contact lens wearer;
• Require spectacle lens powers in both eyes;
• Sphere: between -0.50 to -6.00 diopters and
• Astigmatism: between -1.25 to -2.00 and
• Axis: 180 ± 20 degrees
• Are willing to wear contact lens in both eyes;
• Have manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/25 in each eye;
• To be eligible for lens dispensing, the subject must have VA of logMAR equivalent of 20/30 or better in each eye with the study lenses and the investigator must judge the fit including toric orientation as acceptable;

You may not qualify if…

• Are participating in any concurrent clinical or research study;
• Have any known active* ocular disease and/or infection;
• Have a systemic condition that in the opinion of the investigator may affect a study outcome variable;
• Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
• Have known sensitivity to the diagnostic pharmaceuticals to be used in the study;
• Are pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
• Are aphakic;
• Have undergone refractive error surgery;

Where it is running

• Clinical Research Center, University of California, Berkeley — Berkeley, California, United States
• Center for Contact Lens Research, University of Waterloo — Waterloo, Ontario, Canada

Full record on ClinicalTrials.gov

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