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

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.

• Authors: M Amrane, C Creuzot-Garcher, P-Y Robert, D Ismail, J-S Garrigue, P-J Pisella, C Baudouin
• Journal: Journal francais d'ophtalmologie (J Fr Ophtalmol) Vol. 37 Issue 8 Pg. 589-98 (Oct 2014) ISSN: 1773-0597 [Electronic] France
• PMID: 25127703 (Publication Type: Clinical Trial, Phase II, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: Copyright © 2014 Elsevier Masson SAS. All rights reserved.

Chemical References

• Cationorm
• Drug Combinations
• Emulsions
• Lissamine Green Dyes
• Ophthalmic Solutions
• Polyvinyl Alcohol
• Povidone
• Fluorescein

Topics

• Administration, Ophthalmic
• Aged
• Drug Combinations
• Dry Eye Syndromes (drug therapy)
• Emulsions (administration & dosage, adverse effects, pharmacology, therapeutic use)
• Female
• Fluorescein
• Humans
• Lissamine Green Dyes
• Male
• Middle Aged
• Ophthalmic Solutions (administration & dosage, adverse effects, pharmacology, therapeutic use)
• Polyvinyl Alcohol (administration & dosage, adverse effects, pharmacology, therapeutic use)
• Povidone (administration & dosage, adverse effects, pharmacology, therapeutic use)
• Severity of Illness Index
• Tears (drug effects)
• Treatment Outcome