NCT03950115.

Trial name or title	Effects and prognostic factors of intensive pulse light treatment for meibomian gland dysfunction
Methods	Study design: randomised controlled trial Study grouping: cross‐over Exclusions after randomisation? Not applicable Percentage of participant follow‐up: not applicable Study duration (of intervention): 8 weeks Was a sample size calculation reported: not reported
Participants	Baseline characteristics IPL + MGX group Number of participants (number of eyes): not reported Sex: not reported Age: not reported IPL + MGX (active comparator) group Number of participants (number of eyes): not reported Sex: not reported Age: not reported Overall Number of participants (number of eyes): 80 (not reported) Sex: not reported Age: not reported Inclusion criteria: clinical diagnosis of MGD Exclusion criteria: medical conditions in which IPL is contraindicated (pregnancy, breastfeeding, lupus and any major uncontrolled health problem); contact lens wearer; previous ocular surgery; previous thermal treatment for dry eye disease (e.g. LipiFlow) Significant pretreatment baseline differences? Not reported Severity of dry eye: not reported
Interventions	IPL + MGX Description: IPL therapy with the M22® (Lumenis, Dreieich, Germany). IPL administered to the skin below the lower eyelid. Before treatment, the eyes will be protected with opaque goggles. Ultrasound gel will be applied to the participant's face from tragus to tragus including the nose in order to conduct the light, help to spread the energy evenly and provide a degree of protection. The intensity of the IPL treatment will range from 9.8 J/cm² to 13 J/cm² according to Fitzpatrick Skin Type Grading. Duration: 4 treatment sessions in total, which are 2 weeks apart Co‐interventions: MGX IPL + MGX (active comparator) Description: note: ACTIVE comparator: IPL therapy will be performed with the M22® (Lumenis, Dreieich, Germany). IPL treatment is going to be administered to the skin below the lower eyelid. Before treatment, the eyes will be protected with opaque goggles. Ultrasound gel will be applied to the participant's face from tragus to tragus including the nose in order to conduct the light, help to spread the energy evenly, and provide a degree of protection. The intensity of the IPL treatment will range from 9.8 J/cm² to 13 J/cm² according to Fitzpatrick Skin Type Grading. Duration: 4 treatment sessions in total, which are 2 weeks apart Co‐interventions: MGX
Outcomes	Primary outcomes: change from baseline tear film BUT at 2 weeks after the last treatment session change from baseline Oxford grade for corneal staining at 2 weeks after the last treatment session change from baseline MGX score at 2 weeks after the last treatment session change from baseline meibum quality score at 2 weeks after the last treatment session change from baseline OSDI at 2 weeks after the last treatment session
Starting date	Start date: 18 April 2019
Contact information	Responsible party: Prof Tae‐Young Chung Samsung Medical Center, Seoul, Republic of Korea
Notes	None

BUT: break‐up time; GVHD: graft‐versus‐host disease; IL: interleukin; IPL: intense pulsed light; LLT: lipid layer thickness; MGA: meibomian gland area; MGD: meibomian gland dysfunction; MGP: meibomian gland probing; MGS: Meibomian Gland Score; MGX: meibomian gland expression; MGYLSS: Meibomian Glands Yielding Secretion Score; OSDI: Ocular Surface Disease Index; RNA: ribonucleic acid; SANDE: Symptom Assessment in Dry Eye; SPEED: Standard Patient Evaluation of Eye Dryness; TBUT: tear film break‐up time; TGF: transforming growth factor; TMH: tear meniscus height.