title: Clinical efficacy of 0.1% pranoprofen in treatment of dry eye patients: a multicenter, randomized, controlled clinical trial.
abstract: BACKGROUND
  Dry eye is a multifactorial disease of the tears and the ocular surface. This study aimed to investigate the clinical efficacy of a non-steroidal anti-inflammatory drug, pranoprofen, in the treatment of dry eye.
  
  
  METHODS
  It is a prospective, multi-center, randomized, controlled, parallel group study. One hundred and fifteen patients with mild to moderate dry eye disease (55-60 in each treatment group) participated in this multi-center study. Patients were randomly administered with eyedrops containing 0.1% pranoprofen (PRA) plus 0.1% sodium hyaluronate (SH) or SH only, three times daily for 28 days, followed by a 1-week after treatment observation. Dry eye symptom score (DESS), fluorescein corneal staining (FLCS), tear break-up time (TBUT), and Shirmer 1 tear test (ST1, without anesthesia) were evaluated or conducted before treatment and at each study visit. Conjunctival impression cytology was taken from the patients treated with PRA plus SH before and after treatment and real-time polymerase chain reaction (RT-PCR) was performed to detect the changes of human leukocyte antigen DR (HLA-DR) and intercellular adhesion molecule 1 (ICAM-1).
  
  
  RESULTS
  Patients treated with PRA plus SH showed gradual improvements of DESS, FLCS, and TBUT. Between-group comparisons of FLCS and TBUT have statistically significant differences from day 14. Good tolerance with no severe adverse events was found in both groups. Patients treated with PRA plus SH had a reduced expression level of HLA-DR and were statistically different after 28 days of therapy.
  
  
  CONCLUSIONS
  The application of PRA at a dose of 0.1% was well tolerated and benefited to the patients with mild to moderate dry eye disease. The underlying mechanism of its efficacy may be associated with the reduction of inflammatory factors of conjunctival epithelial cells.
authors.affiliation: Eye Institute of Xiamen University, Medical College of Xiamen University, Xiamen, Fujian 361102, China.
authors.forename: Jingyao
authors.initials: J
authors.lastname: Chen
authors.affiliation: Eye Institute of Xiamen University, Medical College of Xiamen University, Xiamen, Fujian 361102, China.
authors.forename: Fei
authors.initials: F
authors.lastname: Dong
authors.affiliation: Affiliated Eye Hospital of Wenzhou Medical Collage, Wenzhou, Zhejiang 325072, China.
authors.forename: Wei
authors.initials: W
authors.lastname: Chen
authors.affiliation: Beijing Institute of Ophthalmology, Department of Ophthalmology, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, China.
authors.forename: Xuguang
authors.initials: X
authors.lastname: Sun
authors.affiliation: West China School of Medicine Sichuan University, Chengdu, Sichuan 610041, China.
authors.forename: Yingping
authors.initials: Y
authors.lastname: Deng
authors.affiliation: Department of Ophthalmology, Peking University Third Hospital, Beijing 100191, China.
authors.forename: Jing
authors.initials: J
authors.lastname: Hong
authors.affiliation: Huazhong University of Science and Technology, Wuhan, Hubei 430022, China.
authors.forename: Mingchang
authors.initials: M
authors.lastname: Zhang
authors.affiliation: Eye Institute of Xiamen University, Medical College of Xiamen University, Xiamen, Fujian 361102, China.
authors.forename: Wenzhao
authors.initials: W
authors.lastname: Yang
authors.affiliation: Eye Institute of Xiamen University, Medical College of Xiamen University, Xiamen, Fujian 361102, China. Email: zuguoliu@xmu.edu.cn.
authors.forename: Zuguo
authors.initials: Z
authors.lastname: Liu
authors.affiliation: Shandong Eye Institute, 5 Yanerdao Road, Qingdao, Shandong 266071, China. Email: lixinxie@public.qd.sd.cn.
authors.forename: Lixin
authors.initials: L
authors.lastname: Xie
mesh_terms: D000328:Adult; D001578:Benzopyrans / Q000627:therapeutic use*; D015352:Dry Eye Syndromes / Q000188:drug therapy*; D006801:Humans; D008875:Middle Aged; D009883:Ophthalmic Solutions / Q000627:therapeutic use*; D011422:Propionates / Q000627:therapeutic use*
chemical_list: D001578:Benzopyrans; D009883:Ophthalmic Solutions; D011422:Propionates; C043940:pyranoprofen