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

Effect of Chitosan-N-acetylcysteine (Lacrimera®) on Subjective Pain Sensation in Corneal Abrasion: a Pilot Study

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.

Study Overview

• Status: Terminated
• Conditions: Eye Diseases
• Intervention / Treatment: Device: Lacrimera

Detailed Description

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
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1140
    • Vienna Institute for Research in Ocular Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; Patients will either be randomized to group 1 (instillation of 1 drop of C-NAC) or group 2 (no instillation of C-NAC) in a 1:1 fashion. Afterwards one drop of C-NAC will be instilled into the study eye of group 1. 1 hour after treatment VAS and the symptom questionnaire will be performed repeatedly in both groups. Both groups will receive antibiotic ointment bandages and antibiotic eye drops for 5 days. Patients assigned to group 1 will receive Lacrimera® for home treatment over the following 5 days. 1 drop of Lacrimera® is supposed to be installed into the eye 20 minutes prior to installation of the respective antibiotic eye drops or ointments.	Device: Lacrimera; 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.
No Intervention: Group 2; Both groups will receive antibiotic ointment bandages and antibiotic eye drops for 5 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS difference	VAS difference between before application and one hour after instillation between the two groups	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative defect size difference	Relative defect size difference as measured by fluorescein slit lamp photography between the visits between the two groups	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	7 days +/- 2 days
Size of haze	Size of haze at 1 week visit between the two groups	7 days +/- 2 days
VAS difference	VAS difference at the one-week visit between the two groups	7 days +/- 2 days

Collaborators and Investigators

• Sponsor: Vienna Institute for Research in Ocular Surgery

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2021
• Primary Completion (Actual): August 31, 2021
• Study Completion (Actual): August 31, 2021

Study Registration Dates

• First Submitted: September 1, 2021
• First Submitted That Met QC Criteria: September 17, 2021
• First Posted (Actual): September 20, 2021

Study Record Updates

• Last Update Posted (Actual): September 20, 2021
• Last Update Submitted That Met QC Criteria: September 17, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Corneal Diseases; Facial Injuries; Eye Injuries; Eye Diseases; Corneal Injuries
• Other Study ID Numbers: Lacrimera Erosio

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No