Clinical trial · Interventional
Changes of Inflammatory Cytokines in the Tears of Moderate and Severe MGD Treated With Topical Loteprednol Etabonate
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Moderate and Severe Meibomiang Gland Dysfunction (Stage 3 or Stage 4 Meibomiang Gland Dysfunction) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| topical loteprednol etabonate (lotemax 0.5%) with warm compress & ocular massage | Drug | — | UNRESOLVED |
| warm compress only group | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Lotemax with warm compress 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
- interventionNames
- Drug: topical loteprednol etabonate (lotemax 0.5%) with warm compress & ocular massage
- type
- ACTIVE_COMPARATOR
- label
- warm compress only group
- description
- warm compress only group
- interventionNames
- Other: warm compress only group
Primary outcomes (1)
- measure
- Changes of inflammatory cytokines in the tears of moderate and severe MGD
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDLee H, Chung B, Kim KS, Seo KY, Choi BJ, Kim TI. Effects of topical loteprednol etabonate on tear cytokines and clinical outcomes in moderate and severe meibomian gland dysfunction: randomized clinical trial. Am J Ophthalmol. 2014 Dec;158(6):1172-1183.e1. doi: 10.1016/j.ajo.2014.08.015. Epub 2014 Aug 13. PMID 25128594