Chitosan derivatives for the treatment of dry eye disease
The dry eye disease (keratoconjunctivitis sicca) is a widespread disease that leads to an unstable tear film, ocular discomfort and visual disturbances. As the tear film fails to cover the entire conjunctiva and cornea, chronic inflammation of the ocular surface occurs. Here we present two studies where the use of chitosan-based eye drops improved the treatment of the disease.
Management of moderate-to-severe dry eye disease using chitosan-N-acetylcysteine (Lacrimera®) eye drops: a retrospective case series
Johannes Nepp, Wolfgang Knoetzl, Anna Prinz, Sonja Hoeller, Martin Prinz. Int Ophthalmol . 2020 Jun;40 (6):1547-1552. doi: 10.1007/s10792-020-01324-5. Epub 2020 Mar 2.
The cause of dry eye disease is insufficient formation of tear fluid or incomplete formation of the three-layer tear film. The main element of treatment is the use of eye drops (artificial tears). Since the disease is chronic, formulations with prolonged efficacy are required. The Lacrimera® eye drops used in the study are based on the biopolymer chitosan-N-acetylcysteine, which forms a protective film on the ocular surface. Lacrimera® is approved as a medical device for the short-term relief of dry eye syndrome symptoms.
In the study, the clinical results of the treatment of patients with moderate to severe disease with Lacrimera® eye drops were investigated. For this purpose, clinical data of 25 patients who received the eye drops for more than 5 days were retrospectively analyzed. Data was collected from the beginning of treatment until one month after treatment. Changes in tear film stability (tear breakup time) and tear formation (Schirmer´s score) were examined. In addition, corneal surface integrity was visualized by corneal fluorescein staining.
Results
- Proportion of patients with intact cornea increased from 12 to 64% (after one month of treatment)
- Prolongation of tear break-up time (=stability of the tear film)
- Increase of the Schirmer score (improvement of tear formation)
- 29% of patients rated the eye drops as effective in relieving eye symptoms
- 30% of patients had no more symptoms after one month of treatment
Conclusion: The study results suggest that the use of chitosan-N-acetylcysteine eye drops is safe and effective. The analysis of the data shows that the effect of Lacrimera® eye drops peaks after 2 weeks and this effect persists for at least 1 month.
Source: https://pubmed.ncbi.nlm.nih.gov/32124131/
Earlier studies investigated the efficiency of Lacrimera® eye drops with chitosan-N-acetylcysteine before.
Early results on the use of chitosan-N-acetylcysteine (Lacrimera ®) in the management of dry eye disease of varied etiology.
Marco Messina, Harminder S Dua. Case Reports. Int Ophthalmol. 2019 Mar;39(3):693-696. doi: 10.1007/s10792-018-0843-0. Epub 2018 Mar 16.
In the study, 18 patients aged 25-86 years suffering from moderate to severe dry eye disease with superficial punctate keratitis (lesion of the corneal epithelium) received Lacrimera® eye drops. All patients applied 1 drop every morning for 5 days. Prior to treatment, the study participants had used other eye drop products, which were replaced by Lacrimera®. Microscopic examination of the eyes was performed before treatment, 1, and 3 weeks after treatment. The Ocular Surface Disease Index (OSDI) and the degree of corneal damage (Oxford Grading Scale = OGS: 0=none, 5=severe) were recorded.
Results
- significant improvement of corneal epithelium according to the OGS and OSDI for 15 patients after 3 weeks
- no improvement for 3 patients
Conclusion: Daily single-dose application of chitosan-N-acetylcysteine eye drops for 5 days improved symptoms of dry eye disease patients. Therefore, Lacrimera® eye drops could be a practicable and efficient alternative.