Protocol for a parallel assignment prospective, randomised, comparative trial to evaluate the safety and efficacy of intense pulsed light (IPL) combined with 3% diquafosol (DQS) ophthalmic solution in dry eye syndrome.

Abstract

INTRODUCTION:

Evaporative dry eye (EDE) is common and can lead to ocular pain, decreased visual quality and reduced quality of life. Intense pulsed light (IPL) and 3% diquafosol ophthalmic solution have been found to be beneficial in reducing signs and symptoms of dry eye.

METHODS AND ANALYSIS:

A randomised clinical trial will be performed at He Eye Specialist Hospital in Shenyang. 360 dry eye disease patients will be equally divided randomly into the IPL group, DQS group (3% diquafosol ophthalmic solution eye-drops) and IPL+group (IPL combined with 3% diquafosol eye-drops). All groups will be followed up for 4 weeks. The primary outcome measures will be the non-invasive tear break-up time and the Ocular Surface Disease Index change from the baseline. The secondary outcome measures willincludeconjunctival and cornea staining with fluorescein and lissamine, meibomian gland function and secretion quality, tear film lipid layer score, tear meniscus height, conjunctival hyperemia (redness score) changes . Adverse events also will be monitored and documented.

DISCUSSION:

This study aimed to assess whether the combination of IPL with 3% diquafosol ophthalmic solution (study group), IPL+ (study group), is more effective than IPL (active control group) or DQS (active control group) in participants with EDE.

ETHICS AND DISSEMINATION:

Management of dry eye with IPL combined with 3% diquafosol ophthalmic solution, registered on 23 January 2023. Ethics approval number: IRB (2022) K029.01. The study's findings will be shared regardless of the effect's direction.

TRIAL REGISTRATION NUMBER:

NCT05694026.

• Authors: Jiayan Chen, Guanghao Qin, Liangzhe Li, Yifan Qi, Huixin Che, He Huang, Yang Xia, Qing Zhang, Yi Wu, Lanting Yang, Salissou Moutari, Jonathan E Moore, Ling Xu, Wei He, Sile Yu, Emmanuel Eric Pazo, Xingru He
• Journal: BMJ open (BMJ Open) Vol. 13 Issue 8 Pg. e073055 (08 29 2023) ISSN: 2044-6055 [Electronic] England
• PMID: 37643847 (Publication Type: Clinical Trial Protocol, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Chemical References

• diquafosol
• Ophthalmic Solutions

Topics

• Humans
• Male
• Dry Eye Syndromes (drug therapy)
• Lacerations
• Ophthalmic Solutions (therapeutic use)
• Prospective Studies
• Quality of Life
• Randomized Controlled Trials as Topic