Status:

COMPLETED

Evaluation of Stenfilcon A Versus Etafilcon A

Lead Sponsor:

CooperVision, Inc.

Conditions:

Myopia

Eligibility:

All Genders

17+ years

Phase:

NA

Brief Summary

Evaluation of two contact lenses

Detailed Description

One week dispensing, investigator-masked, randomized, contralateral study comparing the test lens against the control lens. Each subject will be randomized to wear the test lens in one eye and the con...

Eligibility Criteria

Inclusion

  • Is at least 17 years of age 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 correctable to a visual acuity of 20/30 or better (in each eye) with their habitual correction and the assigned study lenses;
  • Has astigmatism less than or equal to -1.00D;
  • Is an adapted soft contact lens wearer;
  • Demonstrates an acceptable fit with the study lenses;
  • Has no active anterior segment disease or known ocular disease.

Exclusion

  • A person will be excluded from the study if he/she:
  • Has never worn contact lenses before;
  • Has any systemic disease affecting ocular health;
  • Is using any systemic or topical medications that will affect ocular health;
  • Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses;
  • Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye;
  • Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities;
  • Is aphakic;
  • Has undergone corneal refractive surgery;
  • Is participating in any other type of clinical or research study;
  • Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.

Key Trial Info

Start Date :

November 1 2012

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 1 2013

Estimated Enrollment :

46 Patients enrolled

Trial Details

Trial ID

NCT01809834

Start Date

November 1 2012

End Date

November 1 2013

Last Update

July 28 2020

Active Locations (1)

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1

Center for Contact Lens Research, University of Waterloo

Waterloo, Ontario, Canada, N2L 3G1