A randomized, double-masked, placebo-controlled, multicenter comparison of loteprednol etabonate ophthalmic suspension, 0.5%, and placebo for treatment of keratoconjunctivitis sicca in patients with delayed tear clearance

Am J Ophthalmol. 2004 Sep;138(3):444-57. doi: 10.1016/j.ajo.2004.04.052.


Purpose: To evaluate loteprednol etabonate ophthalmic 0.5% suspension, versus placebo for treatment of the inflammatory component of keratoconjunctivitis sicca in patients with delayed tear clearance.

Design: Randomized, double-masked, placebo-controlled clinical trial.

Methods: Sixty-four patients with keratoconjunctivitis sicca and delayed tear clearance were randomly assigned to receive either loteprednol or vehicle 4 times a day for 4 weeks. Patients were evaluated at weeks 2 and 4 of treatment and 2 weeks after treatment was discontinued. Symptoms were scored using a visual analog scale (VAS) of 1 to 100. Corneal fluorescein staining was scored 0 to 4 in five areas. Conjunctival injection was graded 0 to 3 in the inferior bulbar, nasal bulbar, and inferior tarsal areas. Lid margin injection was graded 0 to 3. Safety was assessed by funduscopy, lens examination, biomicroscopy, visual acuity, and Goldmann tonometry, and by monitoring adverse events and changes in symptoms.

Results: In subsets of patients with at least moderate clinical inflammation, there was a significant difference between the loteprednol-treated group and vehicle-treated group after 2 weeks of therapy. The differences did not reach statistical significance at 4 weeks, although the loteprednol-treated patients retained their improvement compared with the vehicle-treated group. Safety evaluations showed both treatments to be well tolerated and similar in the frequency and type of adverse event reported.

Conclusion: The use of topical loteprednol etabonate 0.5% 4 times a day may be beneficial in patients who have keratoconjunctivitis sicca with at least a moderate inflammatory component.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Androstadienes / administration & dosage
  • Androstadienes / adverse effects
  • Androstadienes / therapeutic use*
  • Anti-Allergic Agents / administration & dosage
  • Anti-Allergic Agents / adverse effects
  • Anti-Allergic Agents / therapeutic use*
  • Cornea / metabolism
  • Double-Blind Method
  • Female
  • Fluorescein / metabolism
  • Humans
  • Keratoconjunctivitis Sicca / drug therapy*
  • Keratoconjunctivitis Sicca / metabolism*
  • Loteprednol Etabonate
  • Male
  • Middle Aged
  • Ophthalmic Solutions
  • Pilot Projects
  • Safety
  • Staining and Labeling / methods
  • Suspensions
  • Tears / metabolism*
  • Tonometry, Ocular
  • Visual Acuity


  • Androstadienes
  • Anti-Allergic Agents
  • Ophthalmic Solutions
  • Suspensions
  • Fluorescein
  • Loteprednol Etabonate