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.

Abstract

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.

Trial registration: ClinicalTrials.gov NCT01692652.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Topical
  • Adult
  • Aged
  • Aged, 80 and over
  • Androstadienes / administration & dosage
  • Androstadienes / therapeutic use*
  • Anti-Allergic Agents / administration & dosage
  • Anti-Allergic Agents / therapeutic use*
  • Bandages
  • Cytokines / metabolism*
  • Eye Proteins / metabolism*
  • Eyelid Diseases / classification
  • Eyelid Diseases / drug therapy*
  • Eyelid Diseases / metabolism
  • Female
  • Flow Cytometry
  • Humans
  • Loteprednol Etabonate
  • Male
  • Meibomian Glands / drug effects*
  • Meibomian Glands / metabolism
  • Middle Aged
  • Ophthalmic Solutions
  • Prospective Studies
  • Surveys and Questionnaires
  • Tears / metabolism*

Substances

  • Androstadienes
  • Anti-Allergic Agents
  • Cytokines
  • Eye Proteins
  • Ophthalmic Solutions
  • tear proteins
  • Loteprednol Etabonate

Associated data

  • ClinicalTrials.gov/NCT01692652