Eye Diseases
Conditions
Brief summary
Aim of this pilot study is to evaluate the best treatment regime of Chitosan-N-Acetylcysteine (Lacrimera®) compared to preservative-free, Hyaluronic-acid containing eyedrops (Hylo-Vision® sine).
Detailed description
The present pilot study seeks to investigate the best fitting treatment regime of moderate-to-severe DED with C-NAC compared to preservative-free, Hyaluronic-acid containing eyedrops (Hylo-Vision® sine) by applying a randomized, prospective, adaptive, controlled design.
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.
DEVICEHylo-Vision
Preservative-free, Hyaluronic-acid containing eyedrops (Hylo-Vision® sine).
Sponsors
Vienna Institute for Research in Ocular Surgery
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Masking description
The study will be carried out in an observer-masked fashion, therefore the investigator performing the measurements will not be informed about the treatment group that patients are assigned to.
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age older than 22 years * Corneal staining (marked to severe; NEI grading scale \>=10)
Exclusion criteria
* Usage of eye drops other than lubricants (e.g. antibiotics, steroids, cyclosporin-A) * Usage of systemic antibiotic therapy * Any pathology of the ocular surface except dry eye disease (e.g. corneal scarring, cornea ectasia) * Ocular surgery within prior 3 months to screening * Preceding refractive corneal surgery (e.g. LASIK) * Ocular injury within prior 3 months * 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 * Eyelid abnormalities that affect lid function * Ocular surface abnormality that may compromise corneal integrity * Pregnancy and nursing women (in women of childbearing age a pregnancy test will be performed before inclusion into the study)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of treatment | 1 month | Duration of treatment in days until objectively confirmed recovery (NEI (National Eye Institute) grading ≤1 OR OSDI (Ocular Surface Disease Index) score \<20, either 7±1, 14±1, 21±1 or 28±1 days) in the study group compared to the control group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in BUT (Break Up Time) | 1 month | Change in BUT (Break Up Time) at different visits in both groups. Fluorescein Break Up time is measured after instillation of 100 μl fluorescein into the inferior fornix. Using a stopwatch time after the last blink until the first break up of the tear film is recorded. Three consecutive measurements are performed, and the average is calculated. Non-invasive first and averaged BUT is measured three times and averaged afterwards using the Dry eye module build into the corneal tomography device (Sirius, CSO, Italy). |
| Change in NI-BUT (Non-invasive Break Up Time) | 1 month | Change in NI-BUT (Non-invasive Break Up Time) at different visits in both groups. The Sirius device is a routinely used device for the detailed assessment of the cornea and the tear film. NI-BUT is assessed by monitoring placido discs (Sirius, CSO, Italy) projected onto the cornea. 3 consecutive measurements are made in every eye. |
| OSDI (Ocular Surface Disease Index) | 1 month | OSDI (Ocular Surface Disease Index) at different visits in both groups. The OSDI Questionnaire is a standardized questionnaire to evaluate the subjective disease burden caused by dry eye syndrome. The patients answer up to 12 questions regarding their symptoms. Thereafter, the OSDI Score is calculated. |
| Flourescein staining / Lissamin green staining grading using the NEI Score (National Eye Institute) | 1 month | Lissamin green staining at different visits in both groups using the NEI Score. Fluorescein and Lissamin green dye will be used to examine the anterior surface of the human eye. Anterior Segment Photography will be used to document the findings, which are graded using the National Eye Institute (NEI) grading scale. |
| Change in number of MMP-positive eyes (Matrix Metallopeptidase 9) | 1 month | Change in number of MMP-positive eyes in both groups (Matrix Metallopeptidase 9). MMP-9 is an inflammatory marker of the ocular surface. InflammaDry® allows to indicate elevated levels of MMP-9 in tear fluid by microfiltration technology. Patients will be instructed to look upward, and the lower eye lid will be pulled downward gently. Samples will be collected by dabbing a tear sample collector in 6-8 locations on the palpebral conjunctiva. The test is routinely performed in our dry eye unit. |
Countries
Austria
Outcome results
None listed