PURPOSE: To assess tear cytokine levels and clinical outcomes in moderate and severe meibomian gland dysfunction (MGD) after 2 months of treatment with topical loteprednol etabonate and eyelid scrubs with warm compresses vs eyelid scrubs with warm compresses alone.
DESIGN: Randomized controlled trial.
METHODS: Patients with moderate and severe MGD were randomized into 2 groups: topical loteprednol etabonate and eyelid scrubs with warm compresses (Group I, 34 eyes) or eyelid scrubs with warm compresses (Group II, 36 eyes). We evaluated cytokine levels, tear film break-up time (TBUT), corneal and conjunctival fluorescein staining, biomicroscopic examination of lid margins and meibomian glands, and the Ocular Surface Disease Index before initiating treatment and 1 month and 2 months after treatment.
RESULTS: There were significant decreases in the levels of interleukin (IL)-6, IL-8, and IL-1β in Group I, and IL-6 and IL-8 in Group II. Moreover, the observed decreases of these cytokines in Group I were attributed to a remarkable decrease between treatment and 1 month after treatment. In Group I, there were improvements in all of the clinical outcomes, with prominent improvement in TBUT, corneal and conjunctival fluorescein staining, and meibum quality after 1 month of treatment, compared with Group II. An improvement in meibomian gland expressibility and MGD stage reduction were more remarkable in Group I.
CONCLUSIONS: Topical loteprednol etabonate and eyelid scrubs with warm compresses were tolerated and efficacious for the treatment of moderate and severe MGD. We suggest that such beneficial effects could manifest after 1 month.
Bibliographical noteFunding Information:
All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported. This work was partially supported by the National Research Foundation of South Korea (NRF) grant funded by the South Korea government (MEST No. 2013R1A1A2058907 ) and by the Converging Research Center Program through the Ministry of Science, ICT and Future Planning, South Korea ( 2013K000365 ). The supporters had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. The authors' contributions were as follows: involved in the design of the study (H.L., K.S.K., T.-I.K.); conduct of the study (H.L., K.S.K., B.H.C., T.-I.K.); collection, management, analysis, and interpretation of the data (H.L., K.S.K., K.Y.S., B.H.C., B.J.C., T.-I.K.); preparation of the manuscript (H.L., K.S.K., K.Y.S., T.-I.K.); and review or approval of the manuscript (H.L., K.S.K., K.Y.S., B.H.C., B.J.C., T.-I.K.). This study is registered at http://www.clinicaltrials.gov (identification no. NCT01692652).
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