Effectiveness of Topical Cyclosporin A 0.1%, Diquafosol Tetrasodium 3%, and Their Combination, in Dry Eye Disease.

Purpose: To compare the effectiveness of the topical use of cyclosporin A (CsA) 0.1%, diquafosol (DQS) tetrasodium 3% ophthalmic solution, and their combination in treating dry eye disease in a general health care setting. Methods: This prospective, nonrandomized, observational study analyzed 279 patients. Patients instilled topical CsA 0.1% (Ikervis ® ; Santen Pharmaceutical Co., Ltd., Japan) once daily and/or DQS tetrasodium 3% (Diquas-S ® ; Santen) six times a day for 12 weeks. Objective signs [tear break-up time (TBUT), National Eye Institute (NEI) corneal and conjunctival staining scores] and symptoms [Symptom Assessment in Dry Eye (SANDE) and Dry Eye-related Quality-of-Life Score (DEQS) questionnaires] were evaluated at baseline, week 4, and week 12. Results: Patients ( n  = 279) were mainly female (85.0%) with a mean (SD) age of 50.1 (14.8) years, and received CsA ( n  = 93), DQS ( n  = 99), or CsA/DQS ( n  = 87). Both monotherapies and CsA/DQS combination therapy significantly improved TBUT, NEI corneal and conjunctival staining scores, and SANDE and DEQS scores from baseline to week 12 (all P  < 0.0001). The mean change in TBUT between baseline and week 12 was significantly higher in CsA/DQS combination therapy (2.13 ± 2.41 s) than in CsA monotherapy (1.07 ± 1.71 s; P  = 0.0011). Conclusions: Monotherapy with CsA or DQS and CsA/DQS combination therapy all significantly improved the objective signs and symptoms of dry eyes during 12 weeks of treatment. CsA/DQS combination therapy provides an additional benefit in terms of TBUT compared with CsA alone; however, a randomized controlled trial still needs to be performed to confirm this result.