Eye Diseases
Conditions
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®.
Interventions
DEVICELacrimera
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.
Sponsors
Vienna Institute for Research in Ocular Surgery
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VAS difference | 1 hour | VAS difference between before application and one hour after instillation between the two groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Size of haze | 7 days +/- 2 days | Size of haze at 1 week visit between the two groups |
| VAS difference | 7 days +/- 2 days | VAS difference at the one-week visit between the two groups |
Countries
Austria
Outcome results
None listed