Efficacy of Different Treatment Regimens With Chitosan-N- Acetylcysteine in Moderate-to-severe Dry Eye Disease
NCT ID: NCT05053789
Last Updated: 2021-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
48 participants
INTERVENTIONAL
2021-05-12
2021-08-27
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Chitosan-N-acetylcysteine on Subjective Pain Sensation in Corneal Abrasion
NCT05049642
Local Tolerability of Chitosan-N-acetylcysteine Eye Drops in Healthy Young Volunteers
NCT01278784
Pilot Study to Clinical Evaluate Device Prototypes in Dry Eye Patients
NCT01957670
Efficacy and Safety of Different Hyaluronic Acid Tear Substitutes Formulations in Evaporative Dry Eye
NCT06517667
Safety and Tolerability of Chitosan-N-acetylcysteine Eye Drops in Healthy Young Volunteers
NCT01015209
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1
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.
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.
Group 2
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.
Hylo-Vision
Preservative-free, Hyaluronic-acid containing eyedrops (Hylo-Vision® sine).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Corneal staining (marked to severe; NEI grading scale \>=10)
Exclusion Criteria
* 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)
22 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Vienna Institute for Research in Ocular Surgery
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Prim. Prof. Dr. Oliver Findl, MBA
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Oliver Findl, PrimUnivPrDr
Role: PRINCIPAL_INVESTIGATOR
Vienna Institute for Research in Ocular Surgery
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Vienna Institute for Research in Ocular Surgery
Vienna, , Austria
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Lacrimera Efficacy
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.