RBR-2wbrh3t
Recruiting
Phase 4
Prospective Randomized Multicenter Clinical Trial of a Light-based Heat and Compression under Direct Visualization Novel System (iLUX) for the Treatment of Dry Eye and Meibomian Gland Dysfunction
Clínica Oftalmológica Pereira Gomes0 sitesJuly 8, 2022
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Blepharitis
- Sponsor
- Clínica Oftalmológica Pereira Gomes
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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