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


METHODS
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.
Ono
Masasfumi
M
Department of Ophthalmology, Tokyo Hospital, Tokai University School of Medicine, 1-2-5 Yoyogi, Shibuya-ku, Tokyo 151-0053, Japan. masafumi@tok.u-tokyo.ac.jp
Takamura
Etsuko
E
Shinozaki
Kazumi
K
Tsumura
Tomoko
T
Hamano
Takashi
T
Yagi
Yukiko
Y
Tsubota
Kazuo
K
D003228:Conjunctiva / Q000187:drug effects / Q000378:metabolism; D004311:Double-Blind Method; D004847:Epithelial Cells / Q000187:drug effects / Q000378:metabolism; D019573:Epithelium, Corneal / Q000187:drug effects / Q000378:metabolism; D005260:Female; D015590:Fluorophotometry; D006801:Humans; D008297:Male; D008875:Middle Aged; D018721:Muscarinic Agonists / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010349:Patient Compliance; D011446:Prospective Studies; D011812:Quinuclidines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012395:Rose Bengal; D012449:Safety; D012859:Sjogren's Syndrome / Q000188:drug therapy* / Q000378:metabolism; D013666:Tears / Q000378:metabolism; D013876:Thiophenes; D016896:Treatment Outcome
D018721:Muscarinic Agonists; D011812:Quinuclidines; D013876:Thiophenes; D012395:Rose Bengal; C059240:cevimeline