Efficacy of Different Treatment Regimens With Chitosan-N- Acetylcysteine in Moderate-to-severe Dry Eye Disease

Vienna Institute for Research in Ocular Surgery48 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Eye Diseases

Interventions

LacrimeraDEVICE

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.

Hylo-VisionDEVICE

Preservative-free, Hyaluronic-acid containing eyedrops (Hylo-Vision® sine).

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

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)

Locations (1)

Vienna Institute for Research in Ocular Surgery

Vienna, Austria

Outcomes

Primary Outcomes

Duration of treatment

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.

Time frame: 1 month

Secondary Outcomes

Change in BUT (Break Up Time)

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).

Time frame: 1 month

Change in NI-BUT (Non-invasive Break Up Time)

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.

Time frame: 1 month

OSDI (Ocular Surface Disease Index)

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.

Time frame: 1 month

Flourescein staining / Lissamin green staining grading using the NEI Score (National Eye Institute)

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.

Data from ClinicalTrials.gov

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