ACTRN12616000667415.

Trial name or title	Evaluation of intense pulsed light therapy for dry eye relief
Methods	Study design: randomised controlled trial Study grouping: parallel group Exclusions after randomisation? Not reported Percentage of participant follow‐up: not applicable Study duration (of intervention): 105 days Was a sample size calculation reported? (Yes/No): no
Participants	Baseline characteristics IPL group Number of participants (number of eyes): estimated 50 (100) Sex: not reported Age: not reported Control group Number of participants (number of eyes): estimated 50 (100) Sex: not reported Age: not reported Overall Number of participants (number of eyes): estimated 100 (200) Sex: not reported Age: not reported Inclusion criteria: symptomatic dry eye caused by MGD; aged ≥ 18 years; both genders. Exclusion criteria: contraindications to light therapy, e.g. clinical skin treatments within last 2 months; implants beneath the lower eyelid area, tattoos, semi‐permanent make‐up or pigmented lesions in the treatment area; contact lens wearers must refrain from wearing contacts within 1 week of commencing the study, and during the study; individuals taking prescribed photosensitising medications such as doxycycline within 3 months of study commencement Significant pretreatment baseline differences? Not reported Severity of dry eye: not reported
Interventions	IPL Description: 4 adjacent, but overlapping IPL pulses (E‐Eye IPL device, E‐Swin, France) will be administered to the skin area immediately below the lower eyelid at an intensity level related to the individual's Fitzpatrick Skin Type (9–13 J/cm²). Duration: 20 seconds per eye Co‐interventions: none Control Description: the E‐Eye IPL device will be administered to the skin area immediately below the lower eyelid but no pulses will be directly applied to the area. Duration: 20 seconds per eye Co‐interventions: none
Outcomes	Primary outcomes: change in non‐invasive tear BUT as measured by the OCULUS Keratograph 5M, at baseline, then on days 15, 45, 75 and 105 after intervention commencement; change in LLT as graded from interference patterns observed on imaging by the OCULUS Keratograph 5M at baseline, then on days 15, 45, 75 and 105 after intervention commencement; change in SANDE questionnaire score, which comprises of 2 questions that use a 100 mm horizontal linear visual analogue scale to quantify both severity and frequency of dry eye symptoms at baseline, then on days 15, 45, 75 and 105 after intervention commencement. Secondary outcomes: change in best spectacle corrected visual acuity (logMAR) at baseline, then on days 15, 45, 75 and 105 after intervention commencement; change in OSDI questionnaire score at baseline, then on days 15, 45, 75 and 105 after intervention commencement; change in TMH (tear fluid adjacent to the lower eyelid) will be digitally analysed to determine the exact TMH by the OCULUS Keratograph 5M at baseline, then on days 15, 45, 75 and 105 after intervention commencement; change in bulbar conjunctival redness (redness of the white part of the eye) will be digitally analysed using a coloured image of the eye taken by the OCULUS Keratograph 5M at baseline, then on days 15, 45, 75 and 105 after intervention commencement; change in non‐contact meibography, which involves recording an image of the participant's everted upper and lower eyelid using the OCULUS Keratograph 5M at baseline, and day 105 after intervention commencement; change in central corneal nerve density as determined by imaging with in‐vivo confocal microscopy at baseline, and day 105 after intervention commencement; change in lid margin Demodex mite population as determined by lash epilation with slit lamp biomicroscopy at baseline, and day 105 after intervention commencement; change in ocular bacterial species determined by culturing eyelid margin swabs at baseline, and day 105 after intervention commencement; change in lipid composition within whole tear samples, analysed by mass spectrometry at baseline, and day 105 after intervention commencement; tear osmolarity (saltiness of tear film) as measured non‐invasively with the TearLab System (Tearlab, San Diego, California, US) at baseline, then on days 15, 45, 75 and 105 after intervention commencement; ocular surface staining with lissamine green dye, observed by slit lamp biomicroscopy and graded according to the Oxford scheme at baseline, then on days 15, 45, 75 and 105 after intervention commencement; ocular surface staining with fluorescein sodium dye, observed by slit lamp biomicroscopy and graded according to the Oxford scheme at baseline, then on day 15, 45, 75 and 105 after intervention commencement; tear evaporation rate, assessed non‐invasively with the VapoMeter (Delfin, Finland) at baseline, then on days 15, 45, 75 and 105 after intervention commencement; change in central corneal sensitivity is assessed using validated non‐contact aesthesiometer at baseline, and day 105 after intervention commencement.
Starting date	Anticipated date of first participant recruitment: 24 May 2016 No further update as at 15 July 2019
Contact information	Associate Professor Jennifer P Craig Department of Ophthalmology, The University of Auckland, Private Bag 92019, Auckland 1142, New Zealand Email: jp.craig@auckland.ac.nz Telephone: +6499238173
Notes	None