Evaluation of Stenfilcon A Versus Etafilcon A

NCT ID: NCT01809834

Last Updated: 2020-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2013-11-30

Brief Summary

Evaluation of two contact lenses

Detailed Description

One week dispensing, investigator-masked, randomized, contralateral study comparing the test lens against the control lens. Each subject will be randomized to wear the test lens in one eye and the control lens in the other eye simultaneously.

Conditions

Myopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Etafilcon A

Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously

Group Type: ACTIVE_COMPARATOR

Stenfilcon A

Intervention Type: DEVICE

Stenfilcon A

Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously

Group Type: EXPERIMENTAL

Etafilcon A

Intervention Type: DEVICE

Interventions

Etafilcon A

Intervention Type: DEVICE

Stenfilcon A

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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;
• Has astigmatism less than or equal to -1.00D;
• Is an adapted soft contact lens wearer;
• Demonstrates an acceptable fit with the study lenses;
• Has no active anterior segment disease or known ocular disease.

Exclusion Criteria

• A person will be excluded from the study if he/she:
• Has never worn contact lenses before;
• Has any systemic disease affecting ocular health;
• Is using any systemic or topical medications that will affect ocular health;
• Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses;
• Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye;
• Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities;
• Is aphakic;
• Has undergone corneal refractive surgery;
• Is participating in any other type of clinical or research study;
• Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.

• 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, PhD., FCO

Role: PRINCIPAL_INVESTIGATOR

Univeristy of Waterloo, Canada

Locations

Center for Contact Lens Research, University of Waterloo

Waterloo, Ontario, Canada

Countries

Canada

Other Identifiers

CV-12-57

Identifier Type: -

Identifier Source: org_study_id