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

IntroductionEvaporative 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 analysisA 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.DiscussionThis 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 disseminationManagement 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 numberNCT05694026.

Comparison of non-pharmaceutical treatments for evaporative dry eye: a randomised controlled study protocol

“…The first (screening) appointment is when all participant’s demographic data, such as ocular disease, current/previous drug use and use of eye drops, will be gathered. Gender and ethnicity will not be used as criteria to exclude participants 41 ( table 1 ).…”

Protocol for a parallel assignment prospective, randomised, double-blinded, placebo-controlled trial to evaluate the efficacy of 0.01% atropine for near work-induced transient myopia and myopic progression in China

“…The allocation list is kept in a separate file on a different computer (as described in Chen et al ). 18 …”

“…At the end of the study, a report on the implementation and the status of data management will be compiled and sent to the PI with the locked research data. 18 …”

“…The inspector will analyse the investigator’s adherence to the protocol, the protection of participants' rights and interests, the quality of the CRF and the investigator’s understanding of different standards before submitting inspection reports to the SC. 18 …”

“…If major AEs occur, He Eye Specialist Hospital Certified Review Board will be notified; experimental treatments will be discontinued promptly, and appropriate therapies will be offered. 18 …”