Low-concentration homogenized castor oil eye drops for noninflamed obstructive meibomian gland dysfunction.
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.
Goto
Eiki
E
Department of Ophthalmology, Tokyo Dental College, Chiba, Japan.
Shimazaki
Jun
J
Monden
Yu
Y
Takano
Yoji
Y
Yagi
Yukiko
Y
Shimmura
Shigeto
S
Tsubota
Kazuo
K
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
D004655:Emulsions; D009883:Ophthalmic Solutions; D013501:Surface-Active Agents; C023040:polyethoxylated castor oil; D002368:Castor Oil