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

Phase 4

Recruiting

• Conditions: Blepharitis; C11.496.260

• Registration Number: RBR-2wbrh3t
• Lead Sponsor: Clínica Oftalmológica Pereira Gomes

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-07-08
• Study Completion: 2022-09-01
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

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 index greater 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;

Exclusion Criteria

Ocular surgery in the last 6 months; Cicatricial lid margin disease (symblepharon) identified by slit-lamp examination; Active ocular infection or active ocular inflammation or history of chronic, recurrent ocular inflammation within the prior 3 months; Treatment with LIpiFlow or Intense Pulsed Light Therapy in the previous 12 months; Treatment with omega-3; Use of topical cyclosporine; Use of topical steroids

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
Increasing in baseline tear break-up time at 1-month (9.5 more or less 6.9) and improvement in ocular surface disease index symptom score at 1 month (8.5 more or less 7.5).