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

Sponsor
Vienna Institute for Research in Ocular Surgery (Other)
Overall Status
Terminated
CT.gov ID
NCT05049642
Collaborator
(none)
30
1
2
3.6
8.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Lacrimera
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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.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.
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Effect of Chitosan-N-acetylcysteine (Lacrimera®) on Subjective Pain Sensation in Corneal Abrasion: a Pilot Study
Actual Study Start Date :
May 12, 2021
Actual Primary Completion Date :
Aug 31, 2021
Actual Study Completion Date :
Aug 31, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. VAS difference [1 hour]

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

Secondary Outcome Measures

  1. Relative defect size difference [7 days +/- 2 days]

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

  2. Relative defect depth difference [7 days +/- 2 days]

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

  3. Size of haze [7 days +/- 2 days]

    Size of haze at 1 week visit between the two groups

  4. VAS difference [7 days +/- 2 days]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Vienna Institute for Research in Ocular Surgery Vienna Austria 1140

Sponsors and Collaborators

  • Vienna Institute for Research in Ocular Surgery

Investigators

  • Principal Investigator: Oliver Findl, PrimUnivPrDr, Vienna Institute for Research in Ocular Surgery

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Prim. Prof. Dr. Oliver Findl, MBA, Principal Investigator, Vienna Institute for Research in Ocular Surgery
ClinicalTrials.gov Identifier:
NCT05049642
Other Study ID Numbers:
  • Lacrimera Erosio
First Posted:
Sep 20, 2021
Last Update Posted:
Sep 20, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 20, 2021