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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02423109
• Other study ID #: CV-15-13
• Status: Completed
• Phase: N/A
• First received: April 17, 2015
• Last updated: January 8, 2018
• Start date: September 2015
• Est. completion date: March 2016

Study information

• Verified date: January 2018
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: March 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Astigmatism
• Hyperopia
• Myopia

Intervention

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

Locations

Country	Name	City	State
Canada	Center for Contact Lens Research, University of Waterloo	Waterloo	Ontario
United States	Clinical Research Center, University of California, Berkeley	Berkeley	California

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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