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

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ClinicalTrials.gov Identifier: NCT02332109
Recruitment Status : Completed
First Posted : January 6, 2015
Last Update Posted : June 7, 2016
Sponsor:
Information provided by (Responsible Party):
TRB Chemedica AG

Brief Summary:
Clinical observation to confirm the clinical safety and efficacy of ODM 5 in the treatment of corneal edema caused by Fuchs' endothelial dystrophy.

Condition or disease Intervention/treatment
Fuchs' Endothelial Dystrophy Corneal Edema Device: ODM 5

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
Actual Enrollment : 29 participants
Time Perspective: Prospective
Official Title: ODM 5 in the Treatment of Corneal Edematous Fuchs' Endothelial Dystrophy
Study Start Date : September 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Group/Cohort Intervention/treatment
ODM 5-group Device: ODM 5
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.




Primary Outcome Measures :
  1. Visual acuity (both eyes) [ Time Frame: Day 56 ]
    Measurement of uncorrected and best corrected visual acuity (both eyes)


Secondary Outcome Measures :
  1. Corneal thickness [ Time Frame: Day 0, day 28 and day 56 ]
    Measurement of central corneal thickness (both eyes)

  2. Visual acuity (both eyes) [ Time Frame: Day 0 and day 28 ]
    Measurement of uncorrected and best corrected visual acuity (both eyes)

  3. Contrast perception (Measurement of contrast values (both eyes)) [ Time Frame: Day 0, day 28 and day 56 ]
    Measurement of contrast values (both eyes)

  4. 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

  5. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a Fuchs endothelial dystrophy-induced corneal edema and an ODM 5 therapy recommendation.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02332109


Locations
Germany
Universitätsklinikum Düsseldorf, Augenklinik
Düsseldorf, Germany, 40225
Praxis Dr. Thomas Kaercher
Heidelberg, Germany, 69121
Universitätsklinikum Magdeburg A.ö.R., Universitätsaugenklinik
Magdeburg, Germany, 39120
Augenklinik der Ludwig-Maximilians-Universität (LMU), Klinikum der Universität München
München, Germany, 80336
Sponsors and Collaborators
TRB Chemedica AG

Responsible Party: TRB Chemedica AG
ClinicalTrials.gov Identifier: NCT02332109     History of Changes
Other Study ID Numbers: ODM5FDE-PMCF-DE-2015-01
First Posted: January 6, 2015    Key Record Dates
Last Update Posted: June 7, 2016
Last Verified: June 2016

Keywords provided by TRB Chemedica AG:
Fuchs endothelial dystrophy
oedema
sodium chloride
hyaluronan
sodium hyaluronate

Additional relevant MeSH terms:
Eye Diseases, Hereditary
Fuchs' Endothelial Dystrophy
Corneal Edema
Corneal Dystrophies, Hereditary
Corneal Diseases
Eye Diseases
Genetic Diseases, Inborn
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents