ODM 5 in the Treatment of Corneal Edematous Fuchs' Endothelial Dystrophy

June 6, 2016 updated by: TRB Chemedica AG
Clinical observation to confirm the clinical safety and efficacy of ODM 5 in the treatment of corneal edema caused by Fuchs' endothelial dystrophy.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Patients with a Fuchs' endothelial dystrophy-induced corneal edema and an ODM 5 therapy recommendation prior to their inclusion will be observed in normal practice setting in this post-market clinical follow-up study. In this indication, the use of ODM 5 should extract the fluid excess in the cornea away by an osmotic effect, enabling the cornea to temporarily regain a normal state of hydration. As a consequence, the patient's visual acuity, contrast perception, corneal thickness and ocular complaints/symptoms should improve. The hyaluronan in ODM 5 helps to protect and heal the cornea in case of irritation and thus, enables the cornea to regain a normal state of hydration and participates in improving the quality of vision.

Study Type

Observational

Enrollment (Actual)

29

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Düsseldorf, Germany, 40225
        • Universitätsklinikum Düsseldorf, Augenklinik
      • Heidelberg, Germany, 69121
        • Praxis Dr. Thomas Kaercher
      • Magdeburg, Germany, 39120
        • Universitätsklinikum Magdeburg A.ö.R., Universitätsaugenklinik
      • München, Germany, 80336
        • Augenklinik der Ludwig-Maximilians-Universität (LMU), Klinikum der Universität München

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with a Fuchs endothelial dystrophy-induced corneal edema and an ODM 5 therapy recommendation.

Description

Inclusion Criteria:

  • Presence of corneal oedema caused by Fuchs' endothelial dystrophy
  • Existing ODM 5 recommendation prior to inclusion

Exclusion Criteria:

  • Contact lens wear
  • Hypersensitivity to one of the ODM 5 components
  • Appointment for eye surgery within 8 weeks after date of inclusion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ODM 5-group
ODM 5 is a CE-certified, preservative-free, hyperosmolar ophthalmological solution containing 5% sodium chloride and 0.15% sodium hyaluronate recommended for the reduction of corneal edema. The patient will use ODM 5 on a daily basis in accordance with the instructions for use and as recommended by the investigator over a period of 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual acuity (both eyes)
Time Frame: Day 56
Measurement of uncorrected and best corrected visual acuity (both eyes)
Day 56

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Corneal thickness
Time Frame: Day 0, day 28 and day 56
Measurement of central corneal thickness (both eyes)
Day 0, day 28 and day 56
Visual acuity (both eyes)
Time Frame: Day 0 and day 28
Measurement of uncorrected and best corrected visual acuity (both eyes)
Day 0 and day 28
Contrast perception (Measurement of contrast values (both eyes))
Time Frame: Day 0, day 28 and day 56
Measurement of contrast values (both eyes)
Day 0, day 28 and day 56
Subjective ocular complaints and symptoms (11-point Likert scale)
Time Frame: Day 0, day 28 and day 56

The following ocular complaints or symptoms will be evaluated on an 11-point Likert scale ranging from '0' (no complaints) to '10' (maximum complaints):

  • glare sensitivity
  • burning
  • foreign body sensation
  • halos
  • pruritus
  • blurred vision
  • redness
  • pain
  • tingling
  • stitching
  • dryness
  • watering eyes
Day 0, day 28 and day 56
Safety parameter (Adverse events)
Time Frame: Day 0, day 28 and day 56
Adverse events judged to be unexpected and (possibly) related to ODM 5 will be documented
Day 0, day 28 and day 56

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

December 19, 2014

First Submitted That Met QC Criteria

January 2, 2015

First Posted (Estimate)

January 6, 2015

Study Record Updates

Last Update Posted (Estimate)

June 7, 2016

Last Update Submitted That Met QC Criteria

June 6, 2016

Last Verified

June 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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