Clinical trial NCT05049642: Effect of Chitosan-N-acetylcysteine on Subjective Pain Sensation in Corneal Abrasion
Official title: Effect of Chitosan-N-acetylcysteine (Lacrimera®) on Subjective Pain Sensation in Corneal Abrasion: a Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Eye Diseases
Lead sponsor: Vienna Institute for Research in Ocular Surgery
Sponsor class: OTHER
First posted: 2021-09-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

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®.

Eligibility criteria: 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

Primary outcomes:
measure: VAS difference
timeFrame: 1 hour
Secondary outcomes:
measure: Relative defect size difference
timeFrame: 7 days +/- 2 days
measure: Relative defect depth difference
timeFrame: 7 days +/- 2 days
measure: Size of haze
timeFrame: 7 days +/- 2 days
measure: VAS difference
timeFrame: 7 days +/- 2 days
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Vienna Institute for Research in Ocular Surgery
Study officials:
affiliation: Vienna Institute for Research in Ocular Surgery
name: Oliver Findl, PrimUnivPrDr
role: PRINCIPAL_INVESTIGATOR
References: