iLux Treatment for Meibomian Gland Dysfunction

NCT06278584 | Completed FDA Device

• 1 other identifier: 2020001-00
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Summary: Purpose: To compare the safety and efficacy of eyelid treatment with the ILux®-MGD Treatment System in one session versus five sessions of mechanical meibomian gland expression (MMGE) in patients with moderate to severe meibomian gland dysfunction (MGD). Methods: Prospective, randomized, open-label, controlled clinical trial comparing one session of the ILux® MGD Treatment System versus five sessions of MMGE in both eyes of 130 patients aged ≥18 years with OSDI scores ≥13, total MGS of 15 in the lower lid of each eye and NI-TBUT \<10 s, who were randomized 1:1 to ILux® or MMGE.

Conditions

Meibomian Gland Dysfunction; Eyes Dry Chronic

Keywords

Meibomian Gland Dysfunction; ILux®; ocular surface; dry eye

Outcome Measures

Primary Outcomes (2)

• Effectiveness defined as changes from baseline to 1, 3, 6, 9 and 12 months in Non Invasive Tear break-up time (NI-TBUT) in seconds.

  NIBUT measured by SIRIUS device in seconds.

  1 year

• Effectiveness defined as changes from baseline to 1, 3, 6, 9 and 12 months in Meibomian gland scores (MGS).

  Using a Meibomian Gland Evaluator (MGE 1000) to grade a total score for 15 meibomian glands in the lower eyelid evaluated in 3 areas: nasal (5 glands), medial (5 glands), and temporal (5 glands) expressed \& graded from 0 to 3 (0 = no secretion, 1 = inspissated, 2 = cloudy, 3 = clear liquid).

  1 year

Study Arms (2)

iLUX Treatment System

ACTIVE COMPARATOR

The eyelid tissue is warmed by light energy produced by LEDs in the Instrument and transmitted through the precise Outer Pad. The Inner Pad and Eye Shield block light transmission directly into the eye during a treatment temperature sensor and measure the inner and outer eyelid temperatures to maintain a meibum melt temperature of 38-42°C.

Device: iLUX Treatment System

Mechanical Meibomian Gland Expression

ACTIVE COMPARATOR

1. Local heat using an electrical warming mask for 5 minutes. 2. Using a standardized device (Arita Meibomian Gland Compressor, Katena) to apply a standard force to individual glands

Device: iLUX Treatment System

Interventions

iLUX Treatment System DEVICE

Local heat using an electrical warming mask for 5 minutes.

Also known as: Mechanical Meibomian Gland Expression

Mechanical Meibomian Gland Expression; iLUX Treatment System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age at least 18 years
• A history of self-reported dry eye symptoms for two months prior to study enrollment,
• Diagnosis of MGD Low delivery type, with mechanism obstructive and non- cicatricial with scores as follows: Ocular Surface Disease Index (OSDI) questionnaire ≥ 13, Non-Invasive Tear break-up time (NIBUT) lower than 10 seconds (The Sirius anterior segment analyzer (CSO, Florence, Italy).
• Meibomian gland scores (MGS) lower than 15.

You may not qualify if:

• A history of ocular surgery
• Allergic conjunctivitis
• Seborrheic dermatitis
• Rosacea
• Psoriasis
• Punctal plugs or previous punctal cautery
• Anterior or demodex blepharitis
• Cicatricial lid margin disease
• Ocular injury or trauma
• Chemical burns
• Limbal stem cell deficiency
• Active ocular infection or non-dry eye inflammation
• Aqueous-deficient dry eye
• Irregular cornea
• Lid abnormalities and systemic disease conditions

Sponsors & Collaborators

• Clínica de Oftalmología de Cali S.A: lead

Study Sites (1)

Clínica de Oftalmología de Cali S.A

Cali, Valle del Cauca Department, 760036, Colombia

Location

MeSH Terms

Conditions

Meibomian Gland Dysfunction; Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases; Lacrimal Apparatus Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 26, 2024
• Study Start: October 15, 2020
• Primary Completion: February 1, 2021
• Study Completion: February 28, 2022
• Last Updated: February 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: In 3 months
• Access Criteria: Restricted access by request

Locations

CO (1)