A Dispensing Clinical of Fanfilcon A Lens Against Lotrafilcon B Lens Over 1 Month Wear Per Lens

NCT ID: NCT02716298

Last Updated: 2017-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2016-08-31

Brief Summary

This is a study to evaluate the performance of fanfilcon A lens when worn on a daily wear modality over approximately 1 month in comparison to the lotrafilcon B lens.

Detailed Description

This is a 45 subject, 1-month dispensing, crossover, double-masked, randomized, bilateral study comparing the test lens against the control lens. Both test and control lenses will be used in a daily wear modality for 1 month each.

Conditions

Myopia

Study Design

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

Study Groups

fanfilcon A

Study participants are randomized to wear fanfilcon A lens during the crossover study

Group Type: ACTIVE_COMPARATOR

fanfilcon A

Intervention Type: DEVICE

contact lens

lotrafilcon B

Study participants are randomized to wear lotrafilcon B lens during the crossover study.

Group Type: ACTIVE_COMPARATOR

lotrafilcon B

Intervention Type: DEVICE

contact lens

Interventions

fanfilcon A

contact lens

Intervention Type: DEVICE

lotrafilcon B

contact lens

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

A person is eligible for inclusion in the study if he/she:

• Is at least 17 years of age and has full legal capacity to volunteer;
• Has read and signed an information consent letter;
• Is willing and able to follow instructions and maintain the appointment schedule;
• Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual correction and the assigned study lenses;
• Is an adapted soft contact lens wearer (For the purpose of this study: Current lens wear at least 3 days per week, 8 hours each day);
• Demonstrates an acceptable fit with the study lenses.

Exclusion Criteria

A person will be excluded from the study if he/she:

• Is participating in any concurrent clinical or research study;
• Is a habitual wearer of lotrafilcon B or enfilcon A lenses.
• Has any known active* ocular disease and/or infection;
• Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
• Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
• Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
• Is pregnant, lactating or planning a pregnancy at the time of enrollment; (by verbal confirmation at the Screening Visit)
• Is aphakic;
• Has undergone refractive error surgery;

• For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.

• 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

Lyndon Jones

Role: PRINCIPAL_INVESTIGATOR

Director, Centre for Contact Lens Research

Locations

Center for Contact Lens Research, University of Waterloo

Waterloo, Ontario, Canada

Countries

Canada

Other Identifiers

EX-MKTG-64

Identifier Type: -

Identifier Source: org_study_id