Multicenter Dispensing Study of Biofinity Lenses in Extended Range

NCT ID: NCT02060539

Last Updated: 2017-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2014-12-31

Brief Summary

To obtain subjective and objective feedback on the clinical performance of Biofinity lenses after at least two weeks daily wear in existing contact lens wearers compared with their habitual lenses.

Conditions

Myopia; Hyperopia

Study Design

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

Study Groups

Biofinity XR

Participants dispensed Biofinity XR lenses over two weeks of lens wear

Group Type: EXPERIMENTAL

Biofinity XR

Intervention Type: DEVICE

Interventions

Biofinity XR

Intervention Type: DEVICE

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) with their habitual vision correction
• Currently wears soft contact lenses
• They should require contact lens powers between -12.00 and -20.00D or between +8.00 and +15.00D
• Has clear corneas and no active ocular disease
• Demonstrates an acceptable fit with the study lenses.

Exclusion Criteria

• Has any systemic disease affecting ocular health
• Is taking medication, such as antihistamine eye drops, oral and ophthalmic betaadrenergic blockers (e.g. Propanolol, Timolol), anticholinergics, and any prescribed or over-the-counter eye medication, except artificial tears or eye lubricants
• Have any active ocular disease and/or infection that would contraindicate contact lens wear.
• 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.
• Has worn gas permeable contact lenses within the last month.
• Is aphakic
• Has undergone corneal refractive surgery.
• Is participating in any other type of clinical research study
• Female who is currently pregnant or is breast-feeding.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CooperVision, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lyndon Jones

Role: PRINCIPAL_INVESTIGATOR

CCLR, University of Waterloo

Meng Lin

Role: PRINCIPAL_INVESTIGATOR

CRC, University of California Berkeley

Jan Bergmanson

Role: PRINCIPAL_INVESTIGATOR

TERTC, University of Houston

Pete Kollbaum

Role: PRINCIPAL_INVESTIGATOR

CORL, Indiana University

Locations

UC Berkeley Clinica Research Center

Berkeley, California, United States

CORL, Indiana University School of Optometry

Indianapolis, Indiana, United States

TERTC, University of Houston

Houston, Texas, United States

CCLR, University of Waterloo

Waterloo, Ontario, Canada

Countries

United States; Canada

Other Identifiers

CV-13-47

Identifier Type: -

Identifier Source: org_study_id