Back to resultsBilateral Dispensing Study of Fanfilcon A Toric Versus Enfilcon A Toric Lenses
Primary Purpose
Myopia, Hyperopia, Astigmatism
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
fanfilcon A
enfilcon A
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
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;
Sites / Locations
- Clinical Research Center, University of California, Berkeley
- Center for Contact Lens Research, University of Waterloo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
fanfilcon A
enfilcon A
Arm Description
Each subject randomized to wear either the test or control as a matched pair and cross over to the second matched pair.
Each subject randomized to wear either the test or control as a matched pair and cross over to the second matched pair.
Outcomes
Primary Outcome Measures
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)
Comfort Preference
Subjective assessment for comfort preference for each lens pair. Choices: fanfilcon A lens, enfilcon A lens, No preference.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02423109
Brief Title
Bilateral Dispensing Study of Fanfilcon A Toric Versus Enfilcon A Toric Lenses
Official Title
Bilateral Dispensing Study of Fanfilcon A Toric Versus Enfilcon A Toric Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coopervision, Inc.
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
Bilateral dispensing clinical trial of fanfilcon A toric lens verses enfilcon A toric lens over two weeks.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Hyperopia, Astigmatism
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
fanfilcon A
Arm Type
Experimental
Arm Description
Each subject randomized to wear either the test or control as a matched pair and cross over to the second matched pair.
Arm Title
enfilcon A
Arm Type
Active Comparator
Arm Description
Each subject randomized to wear either the test or control as a matched pair and cross over to the second matched pair.
Intervention Type
Device
Intervention Name(s)
fanfilcon A
Intervention Description
contact lens
Intervention Type
Device
Intervention Name(s)
enfilcon A
Intervention Description
contact lens
Primary Outcome Measure Information:
Title
Comfort (Subjective Rating Scale)
Description
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)
Time Frame
Dispensing (Baseline) and 2 weeks
Title
Comfort Preference
Description
Subjective assessment for comfort preference for each lens pair. Choices: fanfilcon A lens, enfilcon A lens, No preference.
Time Frame
Dispensing (Baseline) and 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meng Lin, OD PhD
Organizational Affiliation
Clinical Research Center, University of California, Berkeley
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lyndon Jones, PhD FCO
Organizational Affiliation
Center for Contact Lens Research, University of Waterloo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Research Center, University of California, Berkeley
City
Berkeley
State/Province
California
ZIP/Postal Code
94704
Country
United States
Facility Name
Center for Contact Lens Research, University of Waterloo
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3G1
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Bilateral Dispensing Study of Fanfilcon A Toric Versus Enfilcon A Toric Lenses
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