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

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

Study Overview

• Status: Completed
• Conditions: Astigmatism; Myopia; Hyperopia
• Intervention / Treatment: Device: fanfilcon A; Device: enfilcon A

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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2L 3G1
      • Center for Contact Lens Research, University of Waterloo
• United States
  • California
    • Berkeley, California, United States, 94704
      • Clinical Research Center, University of California, Berkeley

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: fanfilcon A; contact lens; Device: enfilcon A; contact lens
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.	Device: fanfilcon A; contact lens; Device: enfilcon A; contact lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comfort (Subjective Rating Scale)	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)	Dispensing (Baseline) and 2 weeks
Comfort Preference	Subjective assessment for comfort preference for each lens pair. Choices: fanfilcon A lens, enfilcon A lens, No preference.	Dispensing (Baseline) and 2 weeks

Collaborators and Investigators

• Sponsor: CooperVision, Inc.
• Investigators: Principal Investigator: Meng Lin, OD PhD, Clinical Research Center, University of California, Berkeley; Principal Investigator: Lyndon Jones, PhD FCO, Center for Contact Lens Research, University of Waterloo

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: April 17, 2015
• First Submitted That Met QC Criteria: April 21, 2015
• First Posted (Estimate): April 22, 2015

Study Record Updates

• Last Update Posted (Actual): January 10, 2018
• Last Update Submitted That Met QC Criteria: January 8, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism; Hyperopia
• Other Study ID Numbers: CV-15-13

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes