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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01692652
First received: September 17, 2012
Last updated: February 17, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Moderate and Severe Meibomiang Gland Dysfunction (Stage 3 or Stage 4 Meibomiang Gland Dysfunction)
Drug: topical loteprednol etabonate (lotemax 0.5%) with warm compress & ocular massage
Other: warm compress only group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Changes of inflammatory cytokines in the tears of moderate and severe MGD [ Time Frame: 1 second before using topical loteprednol etabonate, after 1 month, and after 2 months of using topical loteprednol etabonate ] [ Designated as safety issue: No ]
    Cytokines were measured using the BD Cytometric Bead Array (CBA) (BD Bioscience, San Jose, CA). The cytokines analyzedwere IL-6, IL-7, IL-8, IL-1β, IL-17α, MCP-1, TNF-α, IL-12p70, and IFN-γ. Briefly, 20 μL tear fluid was thawed and added to a 50 μL mixture containing each capture antibody-bead reagent and 50 μL detector antibody-phycoerithrin (Ab-PE) reagent. The mixture was subsequently incubated for 3 h at room temperature, and washed to remove unbound detector Ab-PE reagent before flow cytometry. Data were acquired and analyzed using BD CBA software that calculates the cytokine concentration based on the standard curves and a four-parameter logistic curve-fitting model. Flow cytometry was performed using the BDTM LSRII system (BD Bioscience, San Jose, CA).


Enrollment: 98
Study Start Date: August 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lotemax with warm compress group
topical loteprednol etabonate (lotemax 0.5%) qid and warm compress & ocular massage (a minimum of four times, once or twice a daily) for 2months
Drug: topical loteprednol etabonate (lotemax 0.5%) with warm compress & ocular massage
Active Comparator: warm compress only group
warm compress only group
Other: warm compress only group

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01692652

Locations
Korea, Republic of
department of Ophthalmology, Yonsei University College of Medicine
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01692652     History of Changes
Other Study ID Numbers: 4-2012-0463
Study First Received: September 17, 2012
Last Updated: February 17, 2014
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Loteprednol etabonate
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014