Lipiflow vs iLux Patient Acceptance and Comfort Study

NCT04454983 | Completed FDA Device

• 1 other identifier: PEC-Sep2019-Lipi-iLux
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

meibomian gland dysfunction; dry eye; Lipiflow; iLux

Outcome Measures

Primary Outcomes (1)

• Procedure Comfort

  Likert-scale questionnaire: 1=strongly disagree, 2=disagree, 3=Undecided, 4=Agree, 5=strongly agree - 1 Question

  5 minutes

Secondary Outcomes (2)

• Procedure Experience

  5 minutes

• Patient Preference

  5 minutes

Study Arms (2)

Lipiflow - All Subjects

EXPERIMENTAL

Both Lipiflow and iLux procedures were performed bilaterally on all subjects on the same day. Subjects were randomized to which procedure they received first. There was a 1-hour wait between procedures.

Device: Lipiflow Thermal Pulsation System

iLux - All Subjects

EXPERIMENTAL

Both Lipiflow and iLux procedures were performed bilaterally on all subjects on the same day. Subjects were randomized to which procedure they received first. There was a 1-hour wait between procedures.

Device: iLux System

Interventions

Lipiflow Thermal Pulsation System DEVICE

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.

Lipiflow - All Subjects

iLux System DEVICE

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.

iLux - All Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject can be of any gender or race
• Subject must be 18 years of age or older at the time of informed consent
• \. Subject must be able to understand and must sign an Informed Consent that has been approved by an IRB 3. Subject must have confirmed diagnosis of Meibomian Gland Dysfunction 4. Subject must agree to not wear contact lenses the day of the Study visit

You may not qualify if:

• History of intraocular or oculoplastic surgery within 6 months of Screening visit
• History of ocular injury or trauma, chemical burns, or limbal stem cell deficiency within 3 months of the Screening visit
• Active ocular infection or active ocular inflammation (including allergic conjunctivitis, vernal or giant papillary conjunctivitis) at time of Screening visit
• History of ocular surface abnormality that may compromise corneal integrity
• History of treatment with LipiFlow or iLux in either eye in the last 6 months
• Allergy to topical proparacaine eye drops

Sponsors & Collaborators

• Epstein, Arthur B., OD, FAAO: lead
• Johnson & Johnson Vision Care, Inc.: collaborator

Study Sites (1)

Phoenix Eye Care

Phoenix, Arizona, 85032, United States

Location

Related Links

• Comparison Between iLux™ and LipiFlow® in the Treatment of Meibomian Gland Dysfunction

MeSH Terms

Conditions

Meibomian Gland Dysfunction; Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases; Lacrimal Apparatus Diseases

Study Officials

• Arthur B Epstein, OD

  Ophthalmic Research Consultants of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDIV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Dry Eye and Ocular Surface Disease

Model Details: This study is an open-label, single site, crossover trial comparing LipiFlow Thermal Pulsation System to the iLux System based on patient acceptance, comfort, and preference.

Study Record Dates

• First Submitted: June 28, 2020
• First Posted: July 2, 2020
• Study Start: January 11, 2020
• Primary Completion: February 29, 2020
• Study Completion: February 29, 2020
• Last Updated: August 19, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)