- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02332109
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
Conditions
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
-
-
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Düsseldorf, Germany, 40225
- Universitätsklinikum Düsseldorf, Augenklinik
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Heidelberg, Germany, 69121
- Praxis Dr. Thomas Kaercher
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Magdeburg, Germany, 39120
- Universitätsklinikum Magdeburg A.ö.R., Universitätsaugenklinik
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München, Germany, 80336
- Augenklinik der Ludwig-Maximilians-Universität (LMU), Klinikum der Universität München
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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):
|
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.
Sponsor
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
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ODM5FDE-PMCF-DE-2015-01
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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