Effectiveness of Intense Pulsed Light for Improving Dry Eye Syndrome

Status Completed

Clinical Trial 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.

Clinical Trial Description

Outcome measures (tear break-up time,meibography, self-assessed symptoms and close up photos of the lid margins) will be measured at baseline. All subjects will receive 4 treatments at 2 weeks intervals. In each treatment session, a subject allocated to the study group will be treated with intense pulsed light (IPL) administered in the malar region, from tragus to tragus including the nose, 2-3 mm below the lower eyelids. Immediately following the IPL administration, the subject will undergo meibomian gland expression (MGX) in both eyelids of both eyes. Subjects in the control arm will receive exactly the same treatment, except that the IPL administration will be sham. A single follow-up will occur at 10 weeks after the baseline (or 4 weeks after the 4th treatment session). At the follow-up, the changes in the outcome measures will be evaluated, and compared between the two arms. For each subject, the duration of the study will be 10 weeks: 1st treatment at baseline; 2nd treatment at 2 weeks after baseline; 3rd treatment at 4 weeks after baseline; 4th treatment at 6 weeks after baseline; and a single follow-up at 10 weeks after baseline). Statistically significant differences between the two arms will support the study hypothesis that IPL treatment itself provides relief to both signs and symptoms of dry eye disease. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03396913
Study type	Interventional
Source	Lumenis Ltd.
Contact
Status	Completed
Phase	N/A
Start date	January 10, 2018
Completion date	August 15, 2019

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02597803` - Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-1	Phase 2/Phase 3
Completed	`NCT02522312` - A Retrospective Analysis of Restasis® Benefits in Dry Eye Contact Lens Patients	N/A
Completed	`NCT01863368` - Clinical Evaluation of Systane® ULTRA Compared to OPTIVE® in Ocular Surface Staining	N/A
Completed	`NCT01753752` - Evaluation of the Corneal Residence Time of Chitosan-N-acetylcysteine Eye Drops in Patients With Dry Eye Syndrome After Single and Multiple Instillation	Phase 2
Completed	`NCT01753687` - Correlation of Different Signs for Assessment of Dry Eye Syndrome	N/A
Completed	`NCT01212471` - A Dose Ranging Study to Evaluate Safety and Efficacy of Bromfenac Ophthalmic Solution in Dry Eye Disease	Phase 3
Completed	`NCT01198782` - Evaluating Safety and Efficacy of FID 112903 Post Discontinuation of Long-term Use of RESTASIS® (Cyclosporine Ophthalmic Emulsion) 0.05%	Phase 4
Completed	`NCT01162954` - Phase I Study to Evaluate the Tolerability of Eye Drop DA-6034 in Healthy Volunteers	Phase 1
Completed	`NCT00544713` - Evaluate the Safety and Efficacy of a New Artificial Tear for Use After LASIK Surgery	N/A
Completed	`NCT00535054` - Study to Assess the Safety and Patients' Satisfaction of Tears Again* in the Treatment of Dry Eye Symptoms	N/A
Completed	`NCT00344721` - A Placebo Controlled Double Masked Clinical Assessment Study of Essential Fatty Acid Supplement and Its Effect on Patients With Apparent Aqueous Deficient Dry Eye Syndrome	N/A
Completed	`NCT03830359` - Efficacy, Safety of T2769 in Dry Eye Disease	N/A
Completed	`NCT04139122` - Safety, PK and Efficacy Study of SJP-0132 in Subjects With Dry Eye Disease	Phase 1/Phase 2
Completed	`NCT02758327` - Evaluation of Tear Osmolarity Over Time With Sustained Use of Thera Tears Lubricating Drops	Phase 4
Completed	`NCT02066051` - IPL and Meibomian Gland Expression to Treat Ocular Rosacea Ocular GVHD	N/A
Completed	`NCT01970917` - Effect of Olixia Pure® Eye Drops on Tear Film Thickness in Healthy Subjects	Phase 4
Completed	`NCT02092207` - Phase 2 Study to Evaluation the Safety and Efficacy of Orally Administered KL7016 in Patients With Dry Eye Syndrome	Phase 2
Completed	`NCT01541891` - Efficacy and Safety of PRO-148 Ophthalmic Solution Versus SYSTANE® in the Treatment of Patients With Dry Eye Syndrome	Phase 2
Completed	`NCT01252121` - Residence Time Evaluation of Systane Ultra Lubricant Eye Drops vs. Hialid and Saline	N/A
Completed	`NCT00765804` - Safety and Efficacy Study of Iontophoresis and Dexamethasone Phosphate to Treat Dry Eye	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.