NCT03518398.

Trial name or title	Effectiveness and safety of intense pulsed light in patients with meibomian gland dysfunction
Methods	Study design: randomised controlled trial Study grouping: parallel group Exclusions after randomisation? Not applicable Percentage of participant follow‐up: not applicable Study duration (of intervention): 45 days Was a sample size calculation reported: not reported
Participants	Baseline characteristics IPL group Number of participants (number of eyes): not reported Sex: not reported Age: not reported Sham IPL group Number of participants (number of eyes): not reported Sex: not reported Age: not reported Overall Number of participants (number of eyes): 114 (not reported) Sex: not reported Age: not reported Inclusion criteria: able to read, understand and sign an informed consent form; aged 18–80 years; Fitzpatrick skin type 1–5; able and willing to comply with the treatment/follow‐up schedule and requirements; presence of meibomian gland on each lower eyelid's meibography; current diagnosis of stage1–4 of MGD in both eyes, according to the International Workshop on Meibomian Gland Dysfunction: Report of the Subcommittee on Management and Treatment of Meibomian Gland Dysfunction. Exclusion criteria: contact lens wearer within past month and throughout the study; recent ocular surgery or eyelid surgery within past 6 months; neuro‐paralysis in the planned treatment area within past 6 months; current use of punctual plugs; precancerous lesions, skin cancer or pigmented lesions in the planned treatment area; uncontrolled infections or uncontrolled immunosuppressive diseases; undergone refractive surgery within past 6 months; diseases in the planned treatment area that could be stimulated by light at 560–1200 nm (e.g. Herpes simplex 1 and 2, systemic lupus erythematosus, porphyria); use of photosensitive medications or herbs that may cause sensitivity to 560–1200 nm light exposure, such as isotretinoin, tetracycline or St John's wort; pregnancy and lactation; radiotherapy to the head or neck within past year, or planned radiotherapy throughout study period; treatment with chemotherapeutic agent within past 8 weeks, or planned chemotherapy throughout study period; any condition revealed during the eligibility screening process whereby the physician deems the person inappropriate for this study; declared legally blind in 1 eye; IPL treatment within past 12 months; LipiFlow treatment, or any equivalent treatments, within past 12 months; Any anti‐glaucomatous eye drop uses within past 3 months and throughout study period. Significant pretreatment baseline differences? Not applicable Severity of dry eye: not reported
Interventions	IPL Description: IPL 9–13 J/cm² according to Fitzpatrick's skin type on days 0, 15 and 45, delivered on the E>Eye (E‐Swin, Paris, France) IPL machine Duration: 45 days, with treatments at days 0, 15 and 45 Co‐interventions: warm compression, lid scrub and non‐preservative ocular lubricants Sham IPL Description: sham IPL 0 J/cm² according to Fitzpatrick's skin type on day 0, 15 and 45 Duration: 45 days, with treatments at day 0, 15 and 45 Co‐interventions: warm compression, lid scrub and non‐preservative ocular lubricants.
Outcomes	Primary outcome: change in fluorescein tear BUT using fluorescein technique at days 0, 15 and 45; and months 3 and 6 Secondary outcomes: change in dry eye symptoms using OSDI, a questionnaire at days 0, 15 and 45; months 3 and 6 change in LLT using LipiView interferometer (TearScience, Morrisville, North Carolina, US) at days 0, 15 and 45; and months 3 and 6 change in Meibomian gland's anatomy by meiboscore using meibography using Keratograph 5M (OCULUS, Wetzlar, Germany) at days 0, 15 and 45; and months 3 and 6 change in ocular surface staining using fluorescein staining technique at days 0, 15 and 45; and months 3 and 6 change in MGX after applying the force onto the eyelids using meibomian gland evaluator at days 0, 15 and 45; and months 3 and 6 change in meibum quality after applying the force onto the eyelids using meibomian gland evaluator at days 0, 15 and 45; and months 3 and 6 change in tear osmolarity using TearLab Osmolarity System (TearLab, San Diego, California, US) at days 0 and 45; and months 3 and 6 change in tear production test (Schirmer's test) using calibrated strips of a non‐toxic filter paper at day 0 and month 3 change in tear cytokines IL‐1 receptor antagonist using Bio‐Plex® 200 system (Bio‐Rad, Hercules, CA) at day 0 and month 3 change in tear cytokines IL‐6 using Bio‐Plex® 200 system (Bio‐Rad, Hercules, CA) at day 0 and month 3
Starting date	3 July 2018 and completed 2 April 2019
Contact information	Principal Investigator: Yonrawee Piyacomn Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand, 10330
Notes	None