NCT02423109

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2015

Shorter than P25 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 22, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

January 10, 2018

Completed
Last Updated

January 10, 2018

Status Verified

January 1, 2018

Enrollment Period

4 months

First QC Date

April 17, 2015

Results QC Date

November 8, 2017

Last Update Submit

January 8, 2018

Conditions

MyopiaHyperopiaAstigmatism

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

fanfilcon A

EXPERIMENTAL

Each subject randomized to wear either the test or control as a matched pair and cross over to the second matched pair.

Device: fanfilcon ADevice: enfilcon A

enfilcon A

ACTIVE COMPARATOR

Each subject randomized to wear either the test or control as a matched pair and cross over to the second matched pair.

Device: fanfilcon ADevice: enfilcon A

Interventions

fanfilcon ADEVICE

contact lens

enfilcon Afanfilcon A
enfilcon ADEVICE

contact lens

enfilcon Afanfilcon A

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clinical Research Center, University of California, Berkeley

Berkeley, California, 94704, United States

Location

Center for Contact Lens Research, University of Waterloo

Waterloo, Ontario, N2L 3G1, Canada

Location

MeSH Terms

Conditions

MyopiaHyperopiaAstigmatism

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Results Point of Contact

Title
Myhanh Nguyen, OD
Organization
CooperVision
mnguyen@coopervision.com
9257306716

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2015

First Posted

April 22, 2015

Study Start

September 1, 2015

Primary Completion

January 1, 2016

Study Completion

March 1, 2016

Last Updated

January 10, 2018

Results First Posted

January 10, 2018

Record last verified: 2018-01

Locations

CA(1)US(1)