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. DESIGN: Randomized, double-masked, placebo-controlled crossover clinical trial. PARTICIPANTS: 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. MAIN OUTCOME MEASURES: 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.
RCT Entities:
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. DESIGN: Randomized, double-masked, placebo-controlled crossover clinical trial. PARTICIPANTS: 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. MAIN OUTCOME MEASURES: 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: Alan Tomlinson; Anthony J Bron; Donald R Korb; Shiro Amano; Jerry R Paugh; E Ian Pearce; Richard Yee; Norihiko Yokoi; Reiko Arita; Murat Dogru Journal: Invest Ophthalmol Vis Sci Date: 2011-03-30 Impact factor: 4.799
Authors: J Daniel Nelson; Jun Shimazaki; Jose M Benitez-del-Castillo; Jennifer P Craig; James P McCulley; Seika Den; Gary N Foulks Journal: Invest Ophthalmol Vis Sci Date: 2011-03-30 Impact factor: 4.799
Authors: Penny A Asbell; Fiona J Stapleton; Kerstin Wickström; Esen K Akpek; Pasquale Aragona; Reza Dana; Michael A Lemp; Kelly K Nichols Journal: Invest Ophthalmol Vis Sci Date: 2011-03-30 Impact factor: 4.799