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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

September 1, 2004

Clinical Trial

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.

Pflugfelder SC, Maskin SL, Anderson B, Chodosh J, Holland EJ, De Paiva CS, Bartels SP, Micuda T, Proskin HM, Vogel R.

Am J Ophthalmol. 2004 Sep;138(3):444-57.
Full text | Metrics.

Main finding: In patients with moderately inflammatory Dry eye disease, loteprednol etabonate 0.5%, there was a significant improvement in conjunctival staining at 2 weeks, although this effect regressed at 4 weeks.

 

  • Purpose: To evaluate loteprednol etabonate ophthalmic suspension 0.5% vs placebo in Dry Eye Disease
  • Study type: Randomized controlled Trial
  • Condition: Dry Eye Disease

Participants: ≥ 18years old with keratoconjunctivitis sicca and delayed tear clearance

 

n=64 patients

 

Intervention:

 

Group 1: Loteprednol QID for 4 weeks
Group 2: vehicle QID for 4 weeks

In a subset of patients with at least moderate clinical inflammation, there was a significant difference (conjunctival staining) between both groups at 2 weeks, although this was non-significant at 4 weeks.

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Updated on March 7th, 2022

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