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



Status:Completed
Conditions:Ocular, Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:17 - Any
Updated:1/12/2018
Start Date:September 2015
End Date:March 2016

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

Evaluation of the clinical performance of an investigational silicone-hydrogel lens called
fanfilcon A (test) compared to a FDA-cleared commercially available contact lens called
enfilcon A toric lens (control) when worn on a daily wear basis over 2 weeks in a randomized,
bilateral, cross-over, dispensing study.

Inclusion Criteria:

- 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;

Exclusion Criteria:

- 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;
We found this trial at
2
sites
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mi
from
Waterloo,
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7 Gauss Way
Berkeley, California 94704
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mi
from
Berkeley, CA
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