Lipiflow vs iLux Patient Acceptance and Comfort Study

Summary

This study was designed to compare patient acceptance, comfort, and preference between two meibomian gland clearing devices (Lipiflow vs, iLux). Primary Objective was to compare patient comfort as assessed by Likert-style scale questionnaire following each bilateral procedure. Secondary Objective was to compare overall experience and treatment preference as assessed by Likert-style questionnaire following each bilateral procedure. Both devices are exempt from IDE regulations \[21 CFR 812.2(c)\].

Conditions

• Meibomian Gland Dysfunction
• Dry Eye

Interventions

DEVICE

Lipiflow Thermal Pulsation System

The LipiFlow Console provides the user interface and control elements of the system, including all software, algorithms and control elements. The Activator, a single-use sterile device, delivers automated therapeutic energies to each meibomian gland. Its contoured design vaults the cornea and protects the eye allowing a maximum therapeutic temperature of 43 degrees Celsius to reach glands from the inner eyelid. Insulation protects the cornea from exceeding a safe 39.5 degrees Celsius, while a pressure feedback loop sends pulsed sequences to expel blockages. Force equalization protects the globe from pressure transmission by focusing energy only on the eyelid. Delivered through the LipiFlow Activator, Vectored Thermal Pulse™ technology applies a combination of heat and pressure to the inner eyelid to safely remove gland obstructions and stagnant gland content. Therapeutic motion provides proximal-to-distal peristalsis to clear gland contents.

DEVICE

iLux System

The iLux™ System is used to apply localized heat and pressure to a patient's eyelids. The system consists of a handheld instrument coupled to a single-use, sterile disposable component that is positioned to bridge the eyelid. The iLux device allows view of the eyelid through a magnifier, then warms the eyelid to 40 to 42˚C, then force-limited compression is applied manually to express the melted meibum from obstructed glands. Warming is accomplished using light energy emitted from LEDs in the Instrument. The LEDs are located behind a clear window on the open end of the Shroud. Two wavelengths of light are used: lime-green (568 nm) and near-infrared (850 nm). A mechanism in the Instrument allows the operator to apply pressure to the eyelid by controlling the movement of the Outer Pad using finger pressure applied to the Compression Control button. The force applied to the Compression Control is measured by a sensor in this mechanism.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.

  collaborator INDUSTRY

• Epstein, Arthur B., OD, FAAO

  lead INDIV

Principal Investigators

• Arthur B Epstein, OD · Ophthalmic Research Consultants of Arizona

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-01-11

Primary Completion

2020-02-29

Completion

2020-02-29

FDA Device

Yes

Countries

• United States

Study Locations