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

NCT05053789 | Terminated

• 1 other identifier: Lacrimera Efficacy
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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).

Conditions

Eye Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in BUT (Break Up Time)

  1 month

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

  1 month

• OSDI (Ocular Surface Disease Index)

  1 month

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

  1 month

• Change in number of MMP-positive eyes (Matrix Metallopeptidase 9)

  1 month

Study Arms (2)

Group 1

EXPERIMENTAL

After enrolment into the study and randomization to the study group (V0) and baseline examinations (V1), patients will receive 1 drop of Lacrimera at the study site and will be instructed to apply one drop of C-NAC into both eyes before bedtime for the following 5 consecutive days and return for a follow-up visit after 7±1 days (V2). Patients will complete a diary describing symptoms during the day, use of Lacrimera and potential side effects until the next visit. If the NEI grading is ≤1 OR the OSDI score \<20 at the next visit, treatment with Lacrimera will be discontinued and one further physical follow-up appointment will be arranged, which will take place 28±2 days after the last physical visit.

Device: Lacrimera

Group 2

ACTIVE COMPARATOR

The study days are conducted in the same way as for the study group. Patients of the control group will receive preservative-free, Hyaluronic-acid containing eyedrops (Hylo-Vision® sine) for 4 times a day as control.

Device: Hylo-Vision

Interventions

Lacrimera DEVICE

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.

Group 1

Hylo-Vision DEVICE

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

Group 2

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age older than 22 years
• Corneal staining (marked to severe; NEI grading scale \>=10)

You may not qualify if:

• 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

Sponsors & Collaborators

• Vienna Institute for Research in Ocular Surgery: lead

Study Sites (1)

Vienna Institute for Research in Ocular Surgery

Vienna, 1140, Austria

Location

MeSH Terms

Conditions

Eye Diseases

Study Officials

• Oliver Findl, PrimUnivPrDr

  Vienna Institute for Research in Ocular Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 1, 2021
• First Posted: September 22, 2021
• Study Start: May 12, 2021
• Primary Completion: August 27, 2021
• Study Completion: August 27, 2021
• Last Updated: September 22, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)