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J Fr Ophtalmol. 2014 Oct;37(8):589-98. doi: 10.1016/j.jfo.2014.05.001. Epub 2014 Aug 13.

Ocular tolerability and efficacy of a cationic emulsion in patients with mild to moderate dry eye disease - a randomised comparative study.

Author information

1
Santen SAS, 1, rue Pierre-Fontaine, 91058 Evry cedex, France. Electronic address: mourad.amrane@santen.fr.
2
Service d'ophtalmologie, CHU de Dijon, 3, rue du Faubourg-Raines, 21000 Dijon, France.
3
Service d'ophtalmologie, CHU Dupuytren, 2, avenue Martin-Luther-King, 87000 Limoges, France.
4
Santen SAS, 1, rue Pierre-Fontaine, 91058 Evry cedex, France.
5
Service d'ophtalmologie, CHU Bretonneau, 2, boulevard Tonnellé, 37000 Tours, France.
6
Service d'ophtalmologie, Centre national d'ophtalmologie des Quinze-Vingts, institut de la vision, université Paris 6, 28, rue de Charenton, 75012 Paris, France; Hôpital Ambroise-Paré, AP-HP, 9, avenue Charles-de-Gaulle, 92100 Boulogne-Billancourt, France; Université de Versailles Saint-Quentin-en-Yvelines, 55, avenue de Paris, 78000 Versailles, France.

Abstract

PURPOSE:

The purpose of this study was to compare the safety and efficacy of a new cationic emulsion (CE) with a formulation of polyvinyl alcohol and povidone (PVA-P) for the treatment of mild to moderate dry eye disease.

METHODS:

This was a multicenter, open-label, comparative study. Patients were randomised to receive CE (Cationorm) or PVA-P (Refresh) (1:1). The following objective criteria were assessed to compare the two eye drops: tear Break-up Time (TBUT), Schirmer's test, lissamine green staining (Van Bijsterveld score), corneal fluorescein staining (Oxford scale) and oculopalpebral examination, on D7 and D28 (end of study). At these visits, ocular symptoms and safety were also assessed.

RESULTS:

Seventy-nine patients were randomised: CE: 44 patients; PVA-P: 35 patients. At D28, improvement was significantly better for TBUT [CE: 1.7 ± 2.4 s; PVA-P: 0.6 ± 1.8 s; P=0.015] and for the Van Bijsterveld score [CE: -1.4 ± 1.2; PVA-P: -0.9 ± 1.2; P=0.046] in the CE group. The same applied for the palpebral erythema score (P=0.023), overall efficacy assessed by the investigators (P<0.001), and symptoms not related to eye drop instillation (P=0.021). Improvement was observed from D7. No difference was observed between the two treatments with regard to ocular safety.

CONCLUSION:

These results suggest that in patients with mild to moderate dry eye, Cationorm, in addition to its moisturizing and lubricating properties, also helps stabilize the tear film due to its oily component. This study demonstrates the benefit of this new pharmaceutical form for the treatment of mild to moderate dry eye disease.

KEYWORDS:

Cationic emulsion; Dry eye; Film lacrymal; Tear film; Émulsion cationique; Œil sec

PMID:
25127703
DOI:
10.1016/j.jfo.2014.05.001
[Indexed for MEDLINE]
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