Therapeutic effect of cevimeline on dry eye in patients with Sjögren's syndrome: a randomized, double-blind clinical study

Am J Ophthalmol. 2004 Jul;138(1):6-17. doi: 10.1016/j.ajo.2004.02.010.


Purpose: Sjögren's syndrome (SS) is a systemic autoimmune disease characterized by salivary and lacrimal glandular destruction leading to symptoms of dry mouth and dry eye. Dryness can also occur in the absence of glandular destruction. Patients with SS have autoantibodies that bind to muscarinic acetylcholine receptors in the exocrine glands. Recently, a muscarinic acetylcholine receptor agonist, cevimeline, has been approved for use against symptoms of dry mouth in patients with SS. In this study, the efficacy of cevimeline in improving symptoms of dry eye was examined.

Design: Prospective, randomized, double-blind, multi-center clinical study.

Methods: Sixty patients were randomly assigned to three groups-placebo; cevimeline, 20 mg three times daily; or cevimeline, 30 mg three times daily-and received treatment for 4 weeks. Patients were evaluated before treatment, at week 2, at the end of treatment, and at the end of a 2- to 4-week follow-up period.

Results: Compared with the placebo, statistically significant differences were seen with cevimeline, 20 mg three times daily, in subjective symptoms, tear dynamics, condition of the corneoconjunctival epithelium, and global improvement rating. No difference was found among the three groups regarding the safe use of the drug.

Conclusions: These results indicate that cevimeline, 20 mg three times daily, is safe and effective in improving symptoms of dry eye in patients with SS. Additional studies, with larger patient populations, are needed to further assess the effectiveness of cevimeline for dry eye.

Publication types

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

MeSH terms

  • Conjunctiva / drug effects
  • Conjunctiva / metabolism
  • Double-Blind Method
  • Epithelial Cells / drug effects
  • Epithelial Cells / metabolism
  • Epithelium, Corneal / drug effects
  • Epithelium, Corneal / metabolism
  • Female
  • Fluorophotometry
  • Humans
  • Male
  • Middle Aged
  • Muscarinic Agonists / administration & dosage
  • Muscarinic Agonists / adverse effects
  • Muscarinic Agonists / therapeutic use*
  • Patient Compliance
  • Prospective Studies
  • Quinuclidines / administration & dosage
  • Quinuclidines / adverse effects
  • Quinuclidines / therapeutic use*
  • Rose Bengal
  • Safety
  • Sjogren's Syndrome / drug therapy*
  • Sjogren's Syndrome / metabolism
  • Tears / metabolism
  • Thiophenes*
  • Treatment Outcome


  • Muscarinic Agonists
  • Quinuclidines
  • Thiophenes
  • Rose Bengal
  • cevimeline