Abstract
Purpose :
Artificial tears (AT) represent the first line therapy for the management of symptoms in mild to moderate dry eye disease (DED). Preservative-free cationic emulsions-based AT or drug vehicles are innovative eye drop formulations with interesting tear film stabilization properties. The aim of the present study was to evaluate the efficacy of a cationic emulsion of cetalkonium chloride (0.005%, CE-CKC) AT on clinical signs of dry eye in a mouse model of DED, and compare its efficacy to various marketed AT.
Methods :
Eight to 12-week-old female C57BL6 mice with tail patches of scopolamine (replaced every other days) were housed in controlled environment room to induce dry eye. At day three, following dry eye confirmation by corneal fluorescein staining (CFS, score 0-15) and phenol red thread (PRT) lacrimation test, the mice (n=10/gp) were treated in both eyes with different AT at their recommended dosing regimen: Vismed (four times a day, ie Qid), Systane Ultra (Qid), Aquarest (Qid), Optive (Qid), Refresh (Qid), Systane Balance (Qid), and CE-CKC (twice a day, ie Bid). The untreated animals group served as control. Aqueous tear production (PRT) and CFS scores were assessed at baseline and at days 3, 6 and 10.
Results :
The PRT lacrimation test confirmed the scopolamine-induced decrease in aqueous production by the lacrimal gland (vs baseline). Changes in lacrimation over time remained small for the different AT. Only the CE-CKC was able to significantly increase tear secretion at day 10 (2.9±0.9 mm) vs day 6 (1.7±0.6 mm). After 7 days of treatment (at day 10), Vismed and Optive were not able to reduce CFS, which increase by 12.4 and 2.3%, respectively. At day 10 the CFS score reduction (vs. dry eye baseline) ranged from -1.7 to -20.9% for the other AT, with CE-CKC ranking first (-20.9%) followed by Aquarest (-12.4%), Systane Ultra (-6.4%), Systane Balance (-5.7%), and Refresh (-1.7%).
Conclusions :
This study indicates that twice daily instillations of the CE-CKC is very effective at decreasing the clinical signs of dry eye. Twice daily instillations of CE performed better than all the other AT instilled four times daily. CE-CKC with its improved clinical efficacy associated to a convenient twice daily dosing regimen represents a promising new AT for the management of moderate to severe signs of DED in patients.
This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.