Clinical Validation of Biofinity Toric MTO (Made To Order) Lenses

NCT ID: NCT02185105

Last Updated: 2017-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2014-06-30

Brief Summary

The study hypothesis is there is no difference in the clinical performance between the test and control lenses, in particular in lens stability, toric mislocation, comfort ratings and anterior segment ocular health findings.

Detailed Description

Evaluate the clinical performance of Biofinity toric MTO lenses against current commercial Biofinity toric lenses over 6 hours of lens wear.

Conditions

Myopia; Astigmatism

Study Design

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

Study Groups

comfilcon A MTO

Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.

Group Type: EXPERIMENTAL

comfilcon A

Intervention Type: DEVICE

Randomized to a test lens in one eye and control lens in the other as a matched pair.

comfilcon A

Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.

Group Type: ACTIVE_COMPARATOR

comfilcon A MTO

Intervention Type: DEVICE

Randomized to a test lens in one eye and control lens in the other as a matched pair.

Interventions

comfilcon A MTO

Randomized to a test lens in one eye and control lens in the other as a matched pair.

Intervention Type: DEVICE

comfilcon A

Randomized to a test lens in one eye and control lens in the other as a matched pair.

Intervention Type: DEVICE

Other Intervention Names

Biofinity Toric MTO; Biofinity Toric

Eligibility Criteria

Inclusion Criteria

• Has had a self-reported 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 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
• Currently wears soft contact lenses.
• Has clear corneas and no active ocular disease.
• Has not worn lenses for at least 12 hours before the examination

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 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, active neovascularization or any central corneal scars.
• Is aphakic.
• 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

Pete S Kollbaum, O.D.

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

CORL, Indiana University

Bloomington, Indiana, United States

Countries

United States

Other Identifiers

CV-14-04

Identifier Type: -

Identifier Source: org_study_id