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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: January 2016

Detailed Description

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.

Interventions

  • Device: fanfilcon A
    • contact lens
  • Device: enfilcon A
    • contact lens

Arms, Groups and Cohorts

  • Experimental: fanfilcon A
    • Each subject randomized to wear either the test or control as a matched pair and cross over to the second matched pair.
  • Active Comparator: enfilcon A
    • Each subject randomized to wear either the test or control as a matched pair and cross over to the second matched pair.

Clinical Trial Outcome Measures

Primary Measures

  • Comfort (Subjective Rating Scale)
    • Time Frame: Dispensing (Baseline) and 2 weeks
    • Participant rating for comfort at dispense visit and at the 2 week follow-up on a subjective rating scale (0-100, 0=cannot be worn. Causes pain,100=Cannot be felt ever)
  • Comfort Preference
    • Time Frame: Dispensing (Baseline) and 2 weeks
    • Subjective assessment for comfort preference for each lens pair. Choices: fanfilcon A lens, enfilcon A lens, No preference.

Participating in This Clinical Trial

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;

Gender Eligibility: All

Minimum Age: 17 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Coopervision, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Meng Lin, OD PhD, Principal Investigator, Clinical Research Center, University of California, Berkeley
    • Lyndon Jones, PhD FCO, Principal Investigator, Center for Contact Lens Research, University of Waterloo

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