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

Eye Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05049642
• Other study ID #: Lacrimera Erosio
• Status: Terminated
• Phase: N/A
• Start date: May 12, 2021
• Est. completion date: August 31, 2021

Study information

• Verified date: September 2021
• Source: Vienna Institute for Research in Ocular Surgery
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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®.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Corneal Injuries
• Eye Diseases

Intervention

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.

Locations

Country	Name	City	State
Austria	Vienna Institute for Research in Ocular Surgery	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Vienna Institute for Research in Ocular Surgery

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS difference	VAS difference between before application and one hour after instillation between the two groups	1 hour
Secondary	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
Secondary	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
Secondary	Size of haze	Size of haze at 1 week visit between the two groups	7 days +/- 2 days
Secondary	VAS difference	VAS difference at the one-week visit between the two groups	7 days +/- 2 days