Safety and Tolerability of Chitosan-N-acetylcysteine Eye Drops in Healthy Young Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01015209

Enrollment

Registered

2009-11-18

Start date

2010-09-30

Completion date

2011-01-31

Last updated

2012-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Syndromes

Keywords

Dry eye syndromes

Brief summary

The dry eye syndrome DES is a highly prevalent ocular disease, in particular in the elderly population. One mainstay of therapy for patients suffering from DES is the use of topically administered lubricants. However, despite many efforts, no ideal formulation has yet been found. Recently, Croma Pharma has introduced chitosan-N-acetylcysteine eye drops, designed for treatment of symptoms related to DES. Chemically, chitosan is a polycationic biopolymer with favourable biological properties such as high biocompatibility and low toxicity. Additionally, the new formulation comprises N-acetylcysteine, which has been used in ophthalmology because of its mucolytic properties for several years. Based on theoretical considerations, one can hypothesize that the new chitosan derivative may show an increased adhesion to mucins of the ocular surface and may therefore be particularly beneficial in reducing the symptoms associated with DES.

Interventions

DEVICEChitosan- N- Acetylcysteine eye drops

Cohort 1: 1 drop once Cohort 2: 2 drops daily for 5 days

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Men and women aged between 18 and 45 years * Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant * Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant * Normal ophthalmic findings, ametropia \< 6 dpt.

Exclusion criteria

* Participation in a clinical trial in the 3 weeks preceding the study * Abuse of alcoholic beverages * Symptoms of a clinically relevant illness in the 3 weeks before the first study day * Ametropia of 6 or more dpt. * Pregnancy

Design outcomes

Primary

Measure	Time frame
Difference between the treated and the non- treated eye with Chitosan- N- Acetylcysteine eye drops	5 weeks

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026