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

NCT05049642 | Terminated

• 1 other identifier: Lacrimera Erosio
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Eye Diseases

Outcome Measures

Primary Outcomes (1)

• VAS difference

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

  1 hour

Secondary Outcomes (4)

• Relative defect size difference

  7 days +/- 2 days

• Relative defect depth difference

  7 days +/- 2 days

• Size of haze

  7 days +/- 2 days

• VAS difference

  7 days +/- 2 days

Study Arms (2)

Group 1

EXPERIMENTAL

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

Group 2

NO INTERVENTION

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

Interventions

Lacrimera 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 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age older than 18 years
• Corneal abrasion less than one third of the cornea

You may not qualify if:

• 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

Sponsors & Collaborators

• Vienna Institute for Research in Ocular Surgery: lead

Study Sites (1)

Vienna Institute for Research in Ocular Surgery

Vienna, 1140, Austria

Location

MeSH Terms

Conditions

Eye Diseases

Study Officials

• Oliver Findl, PrimUnivPrDr

  Vienna Institute for Research in Ocular Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 1, 2021
• First Posted: September 20, 2021
• Study Start: May 12, 2021
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: September 20, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)