One Week Assessment of The Phenacite Lens

NCT ID: NCT02553395

Last Updated: 2020-12-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2015-10-31

Brief Summary

This study will investigate performance criteria over one week of daily wear to determine if the Study Test contact lens performs equivalently to the comfilcon A contact lenses in terms of subjective ratings and of visual performance.

The study test lens was not the final optical design and the study results were not used for the design validation.

Detailed Description

This will be double-masked, randomized, bilateral crossover study comparing the Study Test lens against the comfilcon A control lens, each worn over one week of daily wear.

The study test lens was not the final optical design and the study results were not used for the design validation.

Conditions

Myopia

Study Design

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

Study Groups

Phenacite contact lens

Study Test Contact Lens

Group Type: EXPERIMENTAL

Phenacite (Test) contact lens

Intervention Type: DEVICE

comfilcon A contact lens

Control Contact Lens

Group Type: ACTIVE_COMPARATOR

comfilcon A contact lens

Intervention Type: DEVICE

Interventions

Phenacite (Test) contact lens

Intervention Type: DEVICE

comfilcon A contact lens

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

• Oculo-visual examination in the last two years
• Between 18 and 35 years of age and has full legal capacity to volunteer
• Has read and understood the informed consent letter
• Is willing and able to follow instructions and maintain the appointment schedule
• Is correctable to a visual acuity of 20/25 or better (in each eye) with their habitual correction or 20/20 best corrected
• Currently wears, or has previously successfully worn, soft contact lenses between -1.00D (Diopter) and -4.50D
• Spherical Contact Lens Rx between -1.00 and -4.00 and spectacle cylinder <-0.75
• Currently spends a minimum of 4 hours a day; 5 days a week on digital devices and can replicate this time during the study period
• Is willing and able to wear the study contact lenses a minimum of 10 hours per day; 5 days a week.

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, 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
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CooperVision, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Kollbaum, OD, PhD

Role: PRINCIPAL_INVESTIGATOR

Clinical Optics Research Lab (CORL)

Locations

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

Bloomington, Indiana, United States

Countries

United States

Other Identifiers

CV-15-40

Identifier Type: -

Identifier Source: org_study_id