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

Eye Diseases Clinical Trial

Official title:

Efficacy of Different Treatment Regimens With Chitosan-N- Acetylcysteine (Lacrimera®) in Moderate-to-severe Dry Eye Disease: A Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05053789
• Other study ID #: Lacrimera Efficacy
• Status: Terminated
• Phase: N/A
• Start date: May 12, 2021
• Est. completion date: August 27, 2021

Study information

• Verified date: September 2021
• Source: Vienna Institute for Research in Ocular Surgery
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 48
• Est. completion date: August 27, 2021
• Est. primary completion date: August 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Device:
• Lacrimera
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-Vision
Preservative-free, Hyaluronic-acid containing eyedrops (Hylo-Vision® sine).

Locations

Country	Name	City	State
Austria	Vienna Institute for Research in Ocular Surgery	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Vienna Institute for Research in Ocular Surgery

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 month
Secondary	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).	1 month
Secondary	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.	1 month
Secondary	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.	1 month
Secondary	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.	1 month
Secondary	Change in number of MMP-positive eyes (Matrix Metallopeptidase 9)	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.	1 month