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

NCT ID: NCT02423109

Last Updated: 2018-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2016-03-31

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.

Conditions

Myopia; Hyperopia; Astigmatism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

fanfilcon A

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

Group Type: EXPERIMENTAL

fanfilcon A

Intervention Type: DEVICE

contact lens

enfilcon A

Intervention Type: DEVICE

contact lens

enfilcon A

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

Group Type: ACTIVE_COMPARATOR

fanfilcon A

Intervention Type: DEVICE

contact lens

enfilcon A

Intervention Type: DEVICE

contact lens

Interventions

fanfilcon A

contact lens

Intervention Type: DEVICE

enfilcon A

contact lens

Intervention Type: DEVICE

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;

• Minimum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CooperVision, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Meng Lin, OD PhD

Role: PRINCIPAL_INVESTIGATOR

Clinical Research Center, University of California, Berkeley

Lyndon Jones, PhD FCO

Role: PRINCIPAL_INVESTIGATOR

Center for Contact Lens Research, University of Waterloo

Locations

Clinical Research Center, University of California, Berkeley

Berkeley, California, United States

Center for Contact Lens Research, University of Waterloo

Waterloo, Ontario, Canada

Countries

United States; Canada

Other Identifiers

CV-15-13

Identifier Type: -

Identifier Source: org_study_id