Table 1.

Key clinical trials evaluating topical diquafosol therapy for dry eye disease

Study	Year of publication	Study design	Number of patients (n), study arms	Predominant type of dry eye studied	Duration (weeks)	Results
Tauber et al34	2004	Randomized controlled trial	n=527 Three arms: 1) 1% diquafosol 2) 2% diquafosol 3) placebo	ADDE	24	Schirmer scores and corneal fluorescein staining significantly improved with both 1% and 2% diquafosol. Minor improvement in “clearing of foreign body sensation” on secondary (but not primary) analysis.
Matsumoto et al33	2012	Randomized controlled trial	n=286 Three arms: 1) 1% diquafosol 2) 3% diquafosol 3) placebo	ADDE	6	Corneal and conjunctival staining scores significantly improved with both 1% and 3% topical diquafosol with a dose-dependent effect. eleven ocular symptoms were assessed. Only one (“dry eye sensation”) improved with diquafosol.
Takamura et al35	2012	Randomized controlled trial	n=286 Two arms: 1) 3% diquafosol 2) 0.1% sodium hyaluronate	ADDE	4	Mean fluorescein staining scores and TBUT improved for both groups. No inferiority or superiority detected between groups. Rose bengal staining improved for both groups, with diquafosol superior to hyaluronate. Eleven ocular symptoms were assessed; superiority of diquafosol was demonstrated for one (“heaviness”).
Kamiya et al36	2012	Prospective, consecutive interventional case series	n=32 (64 eyes) For each patient: 1) one eye served as treatment group (sodium hyaluronate and diquafosol) 2) the other eye served as control (sodium hyaluronate)	ADDE insufficiently responsive to sodium hyaluronate monotherapy	4	Diquafosol eyes showed improvement in TBUT and corneal staining but not Schirmer test. Twelve symptoms were measured. Three (“dry eye sensation, pain, and foreign body sensation”) improved in diquafosol eyes.

Abbreviations: ADDE, aqueous tear-deficient dry eye; TBUT, tear film break-up time.