Fuchs' Endothelial DystrophyNCT02332109
ODM 5 in the Treatment of Corneal Edematous Fuchs' Endothelial Dystrophy
An observational study of Fuchs' Endothelial Dystrophy and Corneal Edema, run by TRB Chemedica AG at 4 sites in Germany.
Trial summary
Clinical observation to confirm the clinical safety and efficacy of ODM 5 in the treatment of corneal edema caused by Fuchs' endothelial dystrophy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fuchs' Endothelial Dystrophy, Corneal Edema
- What is being tested?
- ODM 5
- Type of treatment
- Medical device
- How many people
- 29 participants
- Where
- 4 sitesGermany
- Study dates
- Sep 2015to May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a Fuchs endothelial dystrophy-induced corneal edema and an ODM 5 therapy recommendation.
Who may be able to join
- Presence of corneal oedema caused by Fuchs' endothelial dystrophy
- Existing ODM 5 recommendation prior to inclusion
Who cannot join
- Contact lens wear
- Hypersensitivity to one of the ODM 5 components
- Appointment for eye surgery within 8 weeks after date of inclusion
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Universitätsklinikum Düsseldorf, Augenklinik
Düsseldorf, 40225
Praxis Dr. Thomas Kaercher
Heidelberg, 69121
Universitätsklinikum Magdeburg A.ö.R., Universitätsaugenklinik
Magdeburg, 39120
Augenklinik der Ludwig-Maximilians-Universität (LMU), Klinikum der Universität München
München, 80336
About this study
Clinical observation to confirm the clinical safety and efficacy of ODM 5 in the treatment of corneal edema caused by Fuchs' endothelial dystrophy.
Read the 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.
- Conditions
- Fuchs' Endothelial Dystrophy, Corneal Edema
- Being tested
- ODM 5
- Keywords
- Fuchs endothelial dystrophy, oedema, sodium chloride, hyaluronan, sodium hyaluronate
- Medical subject headings
- Fuchs' Endothelial Dystrophy, Corneal Edema, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ODM 5Device
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.
| Study group | Role | What they receive |
|---|---|---|
| ODM 5-group | Not described Receives: Device: ODM 5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity (both eyes)
Measurement of uncorrected and best corrected visual acuity (both eyes)
Measured: Day 56
Secondary outcomes (5)
Corneal thickness
Measurement of central corneal thickness (both eyes)
Measured: Day 0, day 28 and day 56
Visual acuity (both eyes)
Measurement of uncorrected and best corrected visual acuity (both eyes)
Measured: Day 0 and day 28
Contrast perception (Measurement of contrast values (both eyes))
Measurement of contrast values (both eyes)
Measured: Day 0, day 28 and day 56
Subjective ocular complaints and symptoms (11-point Likert scale)
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
Measured: Day 0, day 28 and day 56
Safety parameter (Adverse events)
Adverse events judged to be unexpected and (possibly) related to ODM 5 will be documented
Measured: Day 0, day 28 and day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study startSep 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fuchs' Endothelial DystrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- TRB Chemedica AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02332109
- Sponsor's protocol ID
- ODM5FDE-PMCF-DE-2015-01
- Status last verified
- Jun 2016
- First submitted
- 19 Dec 2014
- Last updated
- 7 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ODM 5 in the Treatment of Corneal Edematous Fuchs' Endothelial Dystrophy
- ClinicalTrials.gov ID
- NCT02332109
- Acronym / sponsor ID
- ODM5FDE-PMCF-DE-2015-01
- Conditions
- Fuchs' Endothelial Dystrophy, Corneal Edema
- Keywords
- Fuchs endothelial dystrophy, oedema, sodium chloride, hyaluronan, sodium hyaluronate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- TRB Chemedica AGIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 6 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical observation to confirm the clinical safety and efficacy of ODM 5 in the treatment of corneal edema caused by Fuchs' endothelial dystrophy.
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 design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ODM 5-group | – | Device: ODM 5 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a Fuchs endothelial dystrophy-induced corneal edema and an ODM 5 therapy recommendation.
Key inclusion criteria (2 listed)
- Presence of corneal oedema caused by Fuchs' endothelial dystrophy
- Existing ODM 5 recommendation prior to inclusion
Key exclusion criteria (3 listed)
- Contact lens wear
- Hypersensitivity to one of the ODM 5 components
- Appointment for eye surgery within 8 weeks after date of inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ODM 5ODM 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. | Device | ODM 5-group |
Primary outcome
Visual acuity (both eyes)
Time frame: Day 56
Measurement of uncorrected and best corrected visual acuity (both eyes)
5 secondary outcomes
Corneal thickness
Time frame: Day 0, day 28 and day 56
Visual acuity (both eyes)
Time frame: Day 0 and day 28
Contrast perception (Measurement of contrast values (both eyes))
Time frame: 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
Safety parameter (Adverse events)
Time frame: Day 0, day 28 and day 56
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2016.
Related trials for Fuchs' Endothelial Dystrophy
Active, not recruitingPhase 3
Descemet Endothelial Thickness Comparison Trial II
Fuchs, Fuchs Dystrophy
RecruitingPhase 2
Study of EO2002 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction
Corneal Edema, Fuchs
RecruitingObservational study
A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
Keratoconus, Ectasia
RecruitingPhase 2
DT-168 in Keratoplasty Patients With Fuchs Endothelial Corneal Dystrophy
Fuchs Endothelial Corneal Dystrophy, Fuchs
Active, not recruiting
The Belgian Endothelial Surgical Transplant of the Cornea
Corneal Edema, Corneal Endothelial Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fuchs' Endothelial Dystrophy and Corneal Edema, run by TRB Chemedica AG at 4 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity (both eyes) (time frame: Day 56). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2016.