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

NCT05053789 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2021-09-22

No results posted yet for this study

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

Interventions

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.

DEVICE

Hylo-Vision

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

Sponsors & Collaborators

  • Vienna Institute for Research in Ocular Surgery

    lead OTHER

Principal Investigators

  • Oliver Findl, PrimUnivPrDr · Vienna Institute for Research in Ocular Surgery

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-12
Primary Completion
2021-08-27
Completion
2021-08-27

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05053789 on ClinicalTrials.gov