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Efficacy and Safety of Topical Diquafosol Ophthalmic Solution for Treatment of Dry Eye: A Systematic Review of Randomized Clinical Trials

Wu, Di PhD; Chen, Wang Qi; Li, Ryan; Wang, Yan MD, PhD

doi: 10.1097/ICO.0000000000000429
Clinical Science

Purpose: 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.

Supplemental Digital Content is Available in the Text.

*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.

Reprints: Yan Wang, MD, PhD, Tianjin Eye Hospital & Eye Institute, Tianjin Key Lab of Ophthalmology and Visual Science, Tianjin Medical University, No 4. Gansu Rd, Heping District, Tianjin 300020, China (e-mail:

The authors have no funding or conflicts of interest to disclose.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Web site (

Received October 19, 2014

Received in revised form January 30, 2015

Accepted February 15, 2015

Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved.