Effect of Chitosan-N-acetylcysteine on Subjective Pain Sensation in Corneal Abrasion

Vienna Institute for Research in Ocular Surgery30 enrolled

Overview

Aim of this study is to investigate the effect of Chitosan-N-acetylcysteine (C-NAC; Lacrimera®, Croma-Pharma GmbH, Leobendorf, Austria) in patients with corneal abrasion less than one third of the corneal surface on subjective pain sensation.

Commonly, standard of care for corneal abrasion is topical antibiotics. Bandage contact lenses may be used in addition, which significantly decrease pain sensation in a vast majority of patients. Recently, a new preservative-free agent consisting of a novel biopolymer, Chitosan-N-acetylcysteine (C-NAC; Lacrimera®, Croma-Pharma GmbH, Leobendorf, Austria) has been approved for the treatment of dry eye syndrome (DES). This agent electrostatically binds to the mucine layer of the tear film, forming a glycocalyx-like structure. In an animal model, the beneficial effect of Chitosan-N-Acetylcysteine on recovery time has been observed. Aim of this study is to investigate the effect of Chitosan-N-acetylcysteine (C-NAC; Lacrimera®, Croma-Pharma GmbH, Leobendorf, Austria) in patients with corneal abrasion less than one third of the corneal surface on subjective pain sensation. It will further explore the extend of corneal healing after use of Lacrimera® over 5 days in those patients initially treated with Lacrimera®.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Eye Diseases

Interventions

LacrimeraDEVICE

A new preservative-free formulation of eye drops consists of a novel biopolymer, chitosan-N-acetylcysteine (C-NAC; Lacrimera®, Croma-Pharma GmbH, Leobendorf, Austria), which electrostatically binds to the mucine layer of the tear film forming a glycocalyx-like structure.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age older than 18 years * Corneal abrasion less than one third of the cornea Exclusion Criteria: * Ocular surgery within prior 3 months in the affected eye * Ocular injury within prior 3 months before abrasion in the affected eye * Ocular herpes of eye or eyelid within prior 3 months * Active ocular infection * Active ocular inflammation or history of chronic, recurrent ocular inflammation within prior 3 months * Ocular surface abnormality that may compromise corneal integrity * Presence of diseases that reduce experience of pain (e.g. Diabetes mellitus) * Pregnancy

Locations (1)

Vienna Institute for Research in Ocular Surgery

Vienna, Austria

Outcomes

Primary Outcomes

VAS difference

VAS difference between before application and one hour after instillation between the two groups

Time frame: 1 hour

Secondary Outcomes

Relative defect size difference

Relative defect size difference as measured by fluorescein slit lamp photography between the visits between the two groups

Time frame: 7 days +/- 2 days

Relative defect depth difference

Relative defect depth difference as measured by AS-OCT at 1-week visit compared to baseline between the two groups

Time frame: 7 days +/- 2 days

Size of haze

Size of haze at 1 week visit between the two groups

Time frame: 7 days +/- 2 days

VAS difference

VAS difference at the one-week visit between the two groups

Time frame: 7 days +/- 2 days

Data from ClinicalTrials.gov

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