Bilateral Dispensing Clinical Trial of Stenfilcon A Against Etafilcon A for Astigmatism

CooperVision, Inc.52 enrolled

Overview

Bilateral dispensing clinical trial of stenfilcon A against etafilcon A for astigmatism.

CooperVision is evaluating the clinical performance of an FDA cleared silicone-hydrogel lens material stenfilcon A (test) compared to etafilcon A for Astigmatism lens (control) when worn on a daily wear basis over one (1) week in a randomized, bilateral, cross-over, dispensing study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Astigmatism

Interventions

stenfilcon A toric lensDEVICE

toric contact lens

etafilcon A toric lensDEVICE

toric contact lens

Eligibility

Sex: ALLMin age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Is at least 17 years of age for Canada and 18 years of age for the USA and has full legal capacity to volunteer; * Has read and signed an information consent letter; * Is willing and able to follow instructions and maintain the appointment schedule; * Is an adapted soft contact lens wearer; * Requires a spherical contact lens prescription between -1.00 to -6.00 inclusive in each eye * Has spectacle astigmatism: -0.50 to -1.50D (Diopter) cylinder (Axis: 90±20, 180±20 in both eyes); * Willing to wear contact lens in both eyes for at least 8 hours per day, 7 days per week; * Has 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 as acceptable. Exclusion Criteria: * Is participating in any concurrent clinical or research study; * Has any known active\* ocular disease and/or infection; * Has a systemic condition that in the opinion of the investigator may affect a study outcome variable; * Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable; * Has known sensitivity to the diagnostic pharmaceuticals to be used in the study; * Is pregnant, lactating (by verbal confirmation at the screening visit); * Is aphakic; * Has undergone refractive error surgery

Locations (2)

Clinical Research Center, University of California, Berkeley

Berkeley, California, United States

Center for Contact Lens Research, University of Waterloo

Waterloo, Ontario, Canada

Outcomes

Primary Outcomes

Comfort

Subjective ratings of lens performance for comfort assessed at baseline and 1 week. Comfort Scale 0-100, 0=extremely uncomfortable/cannot tolerate, 100=extremely comfortable/cannot be felt.