CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 88 enrolled
Drug / intervention
IPL +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03396913
NCT03396913N/ACompleted
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Effectiveness of Intense Pulsed Light for Improving Signs and Symptoms of Dry Eye Disease Due to Meibomian Gland Dysfunction

Lumenis Be Ltd.·interventional·Posted Jan 11, 2018·Updated Dec 9, 2020

In Brief

A clinical study evaluating IPL, Sham IPL, and 1 other intervention for Dry Eye Syndrome. Completed, enrolled 88 participants across 2 sites.

Detailed Summary

The aim of the current study is to examine the contribution of intense pulsed light (IPL) for relieving signs and symptoms of dry eye due to meibomian gland dysfunction. The effect of IPL will be examined in a study designed as a randomized controlled trial. In the study arm, subjects will undergo 4 treatment sessions, consisting of IPL pulses immediately followed by meibomian gland expression (MGX). In the control arm, subjects will undergo the same treatments, except that the IPL pulses will be disabled. For each subject, the duration of the study will be 10 weeks, as explained in the detailed description.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye Syndrome
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJan 11, 2018
Enrollment StartJan 10, 2018
Primary CompletionAug 15, 2019
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 8.5 years ago

Interventions

IPLdevice

Intense pulsed light (IPL) is a non-invasive and non-laser light treatment that is FDA-approved for various conditions in dermatology. Subjects will receive a total of 4 IPL treatments over the course of the study, at intervals of 2 weeks. Each treatment will include applications of 10-15 IPL pulses in the malar region and close to the lower eyelids, followed by meibomian gland expression.

Sham IPLdevice

Sham intense pulsed light (IPL) will be implemented with an IPL device in which all light is blocked by a filter. Subjects will receive a total of 4 sham treatments over the course of the study, at intervals of 2 weeks. Each treatment will include applications of10-15 sham pulses in the malar region and close to the lower eyelids, followed by meibomian gland expression.

MGXprocedure

Meibomian gland expression (MGX) will be implemented by squeezing the meibomian glands with the aid of two Q-tips positioned on either side of the meibomian glands, or with a meibomian gland expressor forceps