Multicenter Clinical Trial for the Treatment of Dry Eye and Meibomian Gland Dysfunction whit iLUX

Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2022
INTERVENTION: Eligible 96 patients, that fulfill the inclusion criteria for dry eye syndrome and blepharitis due to Meibomian gland disfunction. Patients will be divided in two groups: 48 patients treated with iLUX, a device that simultaneously applies localized heat and compression in the eyelids, and 48 patients treated with standard of care (homemade warm lid compress and massage). Each center will be responsible for selecting 32 patients each, that is, 32 patients in Brazil, 32 patients in Colombia and 32 patients in Venezuela, totaling a sample of 96 patients. SP4.031.372.138 CONDITION: Blepharitis C11.496.260 PRIMARY OUTCOME: To evaluate the effectiveness of iLUX treatment in patients with Meibomian gland dysfunction. We expect that the meibomian gland secretion scores increases from baseline measurements (4.0 more or less 3.4) to one month post‐treatment SECONDARY OUTCOME: Increasing in baseline tear break‐up time at 1‐month (9.5 more or less 6.9) and improvement in ocular surface disease inde Xsymptom score at 1 month (8.5 more or less 7.5). INCLUSION CRITERIA: Age over 18 years; Patients who signed the consent form; Availability to attend all study visits; Positive history of dry eye symptoms prior to the study, using ocular surface disease inde Xgreater than or equal to 13 at patient's first visit; Evidence of Meibomian glad disfunction, diagnosed by a clinician not involved in the study and defined as a Meibomian gland secretion score less than 12 in 15 glands assessed in the lower eyelid; Non‐invasive tear film break‐up time (NIBUT) less than 10 seconds using the Keratograph 5M; Consent/ability to abstain from other dry eye/Meibomiun gland disfunction medications during the time between the screening visit and the end of the study;
Epistemonikos ID: 706b7a86ce7a20a7491576d99f3b6b78f726677e
First added on: Aug 26, 2024