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

Primary Purpose

Eye Diseases

Status
Terminated
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Lacrimera
Hylo-Vision
Sponsored by
Vienna Institute for Research in Ocular Surgery
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Eye Diseases

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Vienna Institute for Research in Ocular Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.
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.
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.
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.

Full Information

First Posted
September 1, 2021
Last Updated
September 21, 2021
Sponsor
Vienna Institute for Research in Ocular Surgery
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1. Study Identification

Unique Protocol Identification Number
NCT05053789
Brief Title
Efficacy of Different Treatment Regimens With Chitosan-N- Acetylcysteine in Moderate-to-severe Dry Eye Disease
Official Title
Efficacy of Different Treatment Regimens With Chitosan-N- Acetylcysteine (Lacrimera®) in Moderate-to-severe Dry Eye Disease: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
Medical device expired
Study Start Date
May 12, 2021 (Actual)
Primary Completion Date
August 27, 2021 (Actual)
Study Completion Date
August 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vienna Institute for Research in Ocular Surgery

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eye Diseases

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
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.
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Lacrimera
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Hylo-Vision
Intervention Description
Preservative-free, Hyaluronic-acid containing eyedrops (Hylo-Vision® sine).
Primary Outcome Measure Information:
Title
Duration of treatment
Description
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 Outcome Measure Information:
Title
Change in BUT (Break Up Time)
Description
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
Title
Change in NI-BUT (Non-invasive Break Up Time)
Description
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
Title
OSDI (Ocular Surface Disease Index)
Description
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
Title
Flourescein staining / Lissamin green staining grading using the NEI Score (National Eye Institute)
Description
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.
Time Frame
1 month
Title
Change in number of MMP-positive eyes (Matrix Metallopeptidase 9)
Description
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.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oliver Findl, PrimUnivPrDr
Organizational Affiliation
Vienna Institute for Research in Ocular Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vienna Institute for Research in Ocular Surgery
City
Vienna
ZIP/Postal Code
1140
Country
Austria

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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