NCT03265652.

Trial name or title	IPL and MGX versus MGX alone in the treatment of dry eye disease secondary to MGD
Methods	Study design: randomised controlled trial Study grouping: parallel group Exclusions after randomisation? (If Yes, provide relevant details from the paper): not applicable Percentage of participant follow‐up (include details from all intervention groups): not applicable Study duration (of intervention): 10 weeks Was a sample size calculation reported? (Yes/No): no
Participants	Baseline characteristics IPL group Number of participants (number of eyes): estimated 12 (24) Sex: not reported Age: not reported Control group Number of participants (number of eyes): estimated 12 (24) Sex: not reported Age: not reported Overall Number of participants (number of eyes): estimated 24 (48) Sex: not reported Age: not reported Inclusion criteria: able to read, understand and sign an informed consent form; aged ≥ 18 years; Fitzpatrick skin type I–IV; SPEED questionnaire ≥ 10; OSDI questionnaire ≥ 23; in both eyes, ≥ 5 non‐atrophied meibomian glands on the lower eyelid; in both eyes, tear BUT ≤ 7 seconds; in both eyes, MGA (total MGS for 15 glands of the lower eyelid) ≤ 12. Exclusion criteria: contact lens wear within the month prior to screening; unwilling to discontinue use of contact lenses for duration of study; ocular surgery or eyelid surgery within 6 months prior to screening; neuro‐paralysis in the planned treatment area within 6 months prior to screening; other uncontrolled eye disorders affecting the ocular surface, for example active allergies; current use of punctal plugs; precancerous lesions, skin cancer or pigmented lesions in the planned treatment area; uncontrolled infections or uncontrolled immunosuppressive diseases; ocular infections within 6 months prior to screening; history of cold sores or rashes in perioral area or in the planned treatment area that could be stimulated by light at a wavelength 560–1200 nm (e.g. Herpes simplex 1 or 2, systemic lupus erythematosus, porphyria); use of photosensitive medication or herbs that may cause sensitivity to 560–1200 nm light exposure, such as isotretinoin, tetracycline, doxycycline, or St John's wort within 3 months prior to screening; overexposure to sun within 4 weeks prior to screening, in the judgement of the investigator; administration of prescription eye drops for dry eye within 7 days prior to screening, excluding artificial tears and glaucoma drops; radiotherapy to the head or neck within 12 months prior to screening, or planned radiotherapy within 8 weeks after completion of all IPL treatments; treatment with chemotherapeutic agent within 8 weeks prior to screening, or planned chemotherapy within 8 weeks after completion of all IPL treatments; new topical treatments within the area to be treated, or oral therapies within 3 months prior to screening, except non‐prescription paracetamol‐based analgesics (such as Extra Strength Tylenol®) for pain management after study treatment, new oral omega 3 fatty acid supplements and topical artificial tears; change in dosage of any systemic medication within 3 months prior to screening; anticipated relocation or extensive travel outside of the local study area preventing compliance with follow‐up over the study period; legally blind in either or both eyes; history of migraines, seizures or epilepsy; IPL treatment within 12 months prior to screening; LipiFlow treatment, or any other thermal treatment of the eyelids, within 6 months prior to screening; expression of the meibomian glands within 6 months prior to screening; any condition revealed during the eligibility screening process whereby the investigator deems the person inappropriate for the study; women below the age of menopause (50 years of age). Significant pretreatment baseline differences? Not reported Severity of dry eye: not reported
Interventions	IPL Description of the intervention: quote: "Subjects will receive a total of 4 treatments over the course of the study, at intervals of 2 weeks. Each treatment will include applications of 10–15 IPL pulses in the malar region and close to the lower eyelids, followed by meibomian gland expression." MGX is achieved by squeezing the meibomian glands using 2 Q‐tips. Duration of the intervention: 10 weeks Co‐interventions: MGX. Control Description of the intervention: quote: "Subjects will receive a total of 4 treatments over the course of the study, at intervals of 2 weeks. Each treatment will include a sham application of IPL on 10–15 locations in the malar region and close to the lower eyelids, followed by meibomian gland expression." MGX is achieved by squeezing the meibomian glands using 2 Q‐tips. Duration of the intervention: 10 weeks Co‐interventions: MGX
Outcomes	Primary outcome: change from baseline in TBUT in the study eye at 10 weeks Secondary outcomes: change from baseline in MGA at 10 weeks, in both eyes change from baseline in OSDI at 10 weeks Other outcomes: change from baseline in each of: MGYLS; tear osmolarity; meiboscore (evaluated from meibography); percentage of study eyes with normal TBUT (> 10 seconds); percentage of participants with normal OSDI (score < 23); percentage of participants with normal MGA (score >12); quantitative assessment of the eyelid appearance (from high‐resolution photos of the upper and lower eyelids), at 10 weeks.
Starting date	30 March 2018
Contact information	David Zadok Shmu'el Bait St 12, Jerusalem, 9103102, Israel Email: not reported Telephone: not reported
Notes	None