title: Low-concentration homogenized castor oil eye drops for noninflamed obstructive meibomian gland dysfunction.
abstract: OBJECTIVE
  We developed low-concentration homogenized castor oil eye drops for the treatment of patients with noninflamed obstructive meibomian gland dysfunction (MGD), a major cause of lipid-deficiency dry eye, and assessed the safety, stability, and efficacy of the eye drops.
  
  
  METHODS
  Randomized, double-masked, placebo-controlled crossover clinical trial.
  
  
  METHODS
  Forty eyes of 20 patients with noninflamed MGD.
  
  
  METHODS
  After a preliminary study of eye drops containing castor oil, 2% castor oil and 5% polyoxyethylene castor oil (emulsifier) were mixed to formulate homogenized oil eye drops. The patients were assigned randomly to receive oil eye drops or placebo six times daily for 2 periods of 2 weeks each.
  
  
  METHODS
  At the end of each treatment period, we assessed symptoms, tear interference grade, tear evaporation, fluorescein and rose bengal scores, tear break-up time (BUT), and meibomian gland orifice obstruction. Safety and stability tests were also performed.
  
  
  RESULTS
  Symptom scores, tear interference grade, tear evaporation test results, rose bengal scores, tear BUT, and orifice obstruction scores after the oil eye drop period showed significant improvement compared with the results after the placebo period. No complications attributable to the eye drops were observed. The oil eye drops were stable when stored at 4 degrees C.
  
  
  CONCLUSIONS
  The results indicate that castor oil eye drops are effective and safe in the treatment of MGD. The possible mechanisms of this treatment are improvement of tear stability as a result of lipid spreading, ease of meibum expression, prevention of tear evaporation, and the lubricating effect of the oil eye drops.
authors.affiliation: Department of Ophthalmology, Tokyo Dental College, Chiba, Japan.
authors.forename: Eiki
authors.initials: E
authors.lastname: Goto
authors.forename: Jun
authors.initials: J
authors.lastname: Shimazaki
authors.forename: Yu
authors.initials: Y
authors.lastname: Monden
authors.forename: Yoji
authors.initials: Y
authors.lastname: Takano
authors.forename: Yukiko
authors.initials: Y
authors.lastname: Yagi
authors.forename: Shigeto
authors.initials: S
authors.lastname: Shimmura
authors.forename: Kazuo
authors.initials: K
authors.lastname: Tsubota
mesh_terms: D002368:Castor Oil / Q000008:administration & dosage* / Q000031:analogs & derivatives*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D015352:Dry Eye Syndromes / Q000188:drug therapy / Q000473:pathology; D004655:Emulsions; D005141:Eyelid Diseases / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D006801:Humans; D008297:Male; D008537:Meibomian Glands / Q000187:drug effects* / Q000473:pathology; D008875:Middle Aged; D009883:Ophthalmic Solutions; D011446:Prospective Studies; D012449:Safety; D013501:Surface-Active Agents / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D004655:Emulsions; D009883:Ophthalmic Solutions; D013501:Surface-Active Agents; C023040:polyethoxylated castor oil; D002368:Castor Oil