Expired Study
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Berkeley, California 94704


Purpose:

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


Study summary:

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.


Criteria:

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;


NCT ID:

NCT02423109


Primary Contact:

Principal Investigator
Meng Lin, OD PhD
Clinical Research Center, University of California, Berkeley


Backup Contact:

N/A


Location Contact:

Berkeley, California 94704
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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