Changes of Inflammatory Cytokines in the Tears of Moderate and Severe MGD Treated With Topical Loteprednol Etabonate

Yonsei University

Status: Completed

Conditions: Moderate and Severe Meibomiang Gland Dysfunction (Stage 3 or Stage 4 Meibomiang Gland Dysfunction)

Treatments: Other: warm compress only group; Drug: topical loteprednol etabonate (lotemax 0.5%) with warm compress & ocular massage

Study type: Interventional

Funder types: Other

Identifiers

NCT01692652

4-2012-0463

Details and patient eligibility

About

Meibum lipids are modified in patients with MGD, resulting in tear instability, evaporative dry eye, and eyelid inflammation. These changes add to corneal damages and exacerbate ocular symptoms, which are all associated with the constant release of inflammatory mediators. To our knowledge, there has been no study on tear cytokine levels in MGD patients treated with topical loteprednol etabonate. The investigators, thus, evaluated both inflammatory tear cytokine levels and corresponding clinical outcomes for analyzing the efficacy of topical loteprednol etabonate in moderate and severe MGD. The aim of this research was to determine the concentration of inflammatory tear cytokines in patients with MGD and to compare the changes in tear cytokine levels between topical loteprednol etabonate and warm compress treatment group and warm compress only treatment group.

Enrollment: 98 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

(1) stage 3 or 4 meibomian gland dysfunction

Exclusion criteria

1. history of previous ocular or intraocular surgery
2. ocular infection, non dry eye ocular inflammation, ocular allergy, autoimmune disease,
3. history of intolerance or hypersensitivity to any component of the study medications,
4. wearing contact lenses during the study period, presence of current punctal occlusion,
5. pregnancy, lactating women, and children.
6. Additionally, patients were excluded if they were using any topical ocular or systemic medication that could be used for the treatment MGD or dry eye, including topical or oral antibiotics, topical cyclosporine A, topical or oral steroids, topical non-steroidal anti-inflammatory drugs, topical ocular allergy medications or artificial tears

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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98 participants in 2 patient groups

Lotemax with warm compress group

Experimental group

Description:

topical loteprednol etabonate (lotemax 0.5%) qid and warm compress \& ocular massage (a minimum of four times, once or twice a daily) for 2months

Treatment:

Drug: topical loteprednol etabonate (lotemax 0.5%) with warm compress & ocular massage

warm compress only group

Active Comparator group

Description:

warm compress only group

Treatment:

Other: warm compress only group