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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-12

Study Completion Date

2021-08-31

Brief Summary

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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.

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Detailed Description

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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®.

Conditions

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Eye Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Lacrimera

Intervention Type DEVICE

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.

Group 2

Both groups will receive antibiotic ointment bandages and antibiotic eye drops for 5 days.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No