Format

Send to

Choose Destination
J Ocul Pharmacol Ther. 2017 Jun;33(5):375-382. doi: 10.1089/jop.2016.0123. Epub 2017 Apr 25.

A Controlled, Randomized Double-Blind Study to Evaluate the Safety and Efficacy of Chitosan-N-Acetylcysteine for the Treatment of Dry Eye Syndrome.

Author information

1
1 Department of Clinical Pharmacology, Medical University of Vienna , Vienna, Austria .
2
2 Center for Medical Physics and Biomedical Engineering, Medical University of Vienna , Vienna, Austria .
3
3 Clinical Development, CROMA-PHARMA GmbH , Korneuburg, Austria .
4
4 WardPeterson Consulting, LLC, Morrisville, North Carolina.
5
5 Biostatistics, FGK Clinical Research GmbH , München, Germany .
6
6 Singapore Eye Research Institute , Singapore, Singapore .
7
7 Lee Kong Chian School of Medicine, Nanyang Technological University , Singapore, Singapore .

Abstract

PURPOSE:

This study was designed to evaluate the effect of chitosan-N-acetylcysteine (C-NAC) eye drops on tear film thickness (TFT) in patients with dry eye syndrome (DES).

METHODS:

This was a controlled, randomized, double-blind clinical investigation with patients assigned to 2 cohorts. In Cohort I, 21 patients were randomized to receive 1 instillation of C-NAC eye drops in 1 eye and placebo (normal saline solution) in the contralateral eye. In Cohort II, 17 patients were randomized to receive C-NAC eye drops once (QD) or twice (BID) daily for 5 days. TFT was assessed with a custom-built ultrahigh-resolution optical coherence tomography system.

RESULTS:

In Cohort I, mean TFT increased from 3.9 ± 0.5 μm predose to 4.8 ± 1.1 μm 10 min postdose after treatment with C-NAC. The increase was significantly different from placebo over time (P < 0.0001) and remained stable until 24 h postdose. In Cohort II, TFT increased with QD and BID instillation, with no significant difference between regimens. In both groups, Ocular Surface Disease Index scores improved, fewer patients presented with corneal damage, and symptoms of ocular discomfort/conjunctival redness were reduced.

CONCLUSIONS:

A single instillation of C-NAC significantly increased mean TFT in patients with DES as early as 10 min after instillation and lasted for 24 h. The magnitude of the increase in TFT following a single instillation was comparable with that after instillation twice daily over 5 days. Corneal damage improved in >60% of patients. C-NAC could be a viable treatment option for DES.

KEYWORDS:

dry eye; efficacy; safety; tear film

PMID:
28441068
DOI:
10.1089/jop.2016.0123
[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for Atypon
Loading ...
Support Center