title: Efficacy and safety of topical diquafosol ophthalmic solution for treatment of dry eye: a systematic review of randomized clinical trials.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of topical diquafosol ophthalmic solution for treatment of dry eye.
  
  
  METHODS
  Randomized clinical trials (RCTs) from MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials (CENTRAL) were identified to evaluate the efficacy and safety of topical administration of diquafosol to patients with dry eyes. Data evaluation was based on endpoints including Schirmer test, tear film break-up time, ocular surface staining score, subjective symptom score, and adverse events.
  
  
  RESULTS
  A total of 8 RCTs involving 1516 patients were selected based on the prespecified criteria. Significant improvement of Schirmer test values and tear film break-up time were reported in 40% (2 of 5) and 80% (4 of 5) studies, respectively. Ocular surface staining scores significantly decreased in 100% (fluorescein corneal staining, 6 of 6; Rose Bengal corneal and conjunctival staining, 4 of 4) RCTs. Symptoms significantly improved in 75% (6 of 8) RCTs in patients with dry eyes. No severe adverse events were reported with the concentration of diquafosol from 0.5% to 5%. Heterogeneity in study design prevented meta-analysis from statistical integration and summarization.
  
  
  CONCLUSIONS
  Topical diquafosol seems to be a safe therapeutic option for the treatment of dry eye. The high variability of the selected RCTs compromised the strength of evidence and limits the determination of efficacy. However, the topical administration of diquafosol seems to be beneficial in improving the integrity of the epithelial cell layer of the ocular surface and mucin secretion in patients with dry eyes. This review indicates a need for standardized criteria and methods for evaluation to assess the efficacy of diquafosol in the future clinical trials.
authors.affiliation: *Tianjin Medical University, Tianjin, China; †Tianjin Eye Hospital & Eye Institute, Tianjin Key Lab of Ophthalmology and Visual Science, Tianjin Medical University, Tianjin, China; ‡University of California, Berkeley, College of Chemistry, Berkeley, CA; and §University of Toronto, Faculty of Arts and Science, Sidney Smith Hall, Toronto, Ontario, Canada.
authors.forename: Di
authors.initials: D
authors.lastname: Wu
authors.forename: Wang Qi
authors.initials: WQ
authors.lastname: Chen
authors.forename: Ryan
authors.initials: R
authors.lastname: Li
authors.forename: Yan
authors.initials: Y
authors.lastname: Wang
mesh_terms: D000287:Administration, Topical; D000328:Adult; D000368:Aged; D005260:Female; D019793:Fluorescein; D005456:Fluorescent Dyes; D006801:Humans; D007638:Keratoconjunctivitis Sicca / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions; D011122:Polyphosphates / Q000008:administration & dosage* / Q000009:adverse effects; D058912:Purinergic P2Y Receptor Agonists / Q000008:administration & dosage* / Q000009:adverse effects; D016032:Randomized Controlled Trials as Topic; D012395:Rose Bengal; D013666:Tears / Q000737:chemistry; D016896:Treatment Outcome; D014500:Uracil Nucleotides / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D005456:Fluorescent Dyes; D009883:Ophthalmic Solutions; D011122:Polyphosphates; D058912:Purinergic P2Y Receptor Agonists; D014500:Uracil Nucleotides; D012395:Rose Bengal; C403315:diquafosol; D019793:Fluorescein