Multicenter Dispensing Study of Biofinity Toric Made-To-Order Lenses in Extended Power Ranges

NCT ID: NCT02193178

Last Updated: 2020-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2016-04-30

Brief Summary

The study hypothesis is that the Biofinity Toric XR lenses will perform as well as or better than the participants' habitual contact lenses.

Detailed Description

The study hypothesis is that the Biofinity Toric XR lenses will perform as well as or better than the participants' habitual contact lenses. Further, that a minimum of 80% of those enrolled will complete 2 weeks of lens wear with no contraindication to continue.

Conditions

Myopia; Astigmatism

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

comfilcon A toric

Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.

Group Type: EXPERIMENTAL

comfilcon A Toric

Intervention Type: DEVICE

Contact lenses

Interventions

comfilcon A Toric

Contact lenses

Intervention Type: DEVICE

Other Intervention Names

Biofinity

Eligibility Criteria

Inclusion Criteria

• Has had an oculo-visual examination in the last two years
• Is at least 18 years of age and has full legal capacity to volunteer
• Has read and understood the information consent letter
• Is willing and able to follow instructions and maintain the appointment schedule
• Is correctable to a visual acuity of 20/50 or better (in at least one eye)
• Currently wears soft toric contact lenses in both eyes
• Subject contact lens prescription must fall under one of the contact lens power ranges for at least one eye:

• -20.00D to -10.50D spherical powers and cylinder powers from - 0.75 to -2.25
• +8.50D to +20.00D spherical powers and cylinder powers from - 0.75 to -2.25
• -20.00D to -6.50D spherical powers and cylinder powers from -2.75 to -5.75
• -6.00D to +6.00D spherical powers and cylinder powers from -2.75 to -5.75
• +6.50D to +20.00D spherical powers and cylinder powers from-2.75 to -5.75
• Has clear corneas and no active ocular disease
• Demonstrates an acceptable fit with the study lenses

Exclusion Criteria

• 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 abnormality that would affect the wearing of contact lenses;
• Has undergone corneal refractive surgery;
• Is participating in any other type of eye related clinical or research study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CooperVision, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jan Bergmanson, OD PhD

Role: PRINCIPAL_INVESTIGATOR

Texas Eye Research and Technology Center (TERTC), School of Optometry, University of Houston

Pete Kollbaum, OD PhD

Role: PRINCIPAL_INVESTIGATOR

Clinical Optics Research Lab (CORL), Indiana University School of Optometry, Indiana University

Locations

Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University

Bloomington, Indiana, United States

Texas Eye Research and Technology Center (TERTC) College of Optometry, University of Houston

Houston, Texas, United States

Countries

United States

Other Identifiers

CV-14-05

Identifier Type: -

Identifier Source: org_study_id