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Completed

NCT Number: NCT02332109

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

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

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Key information

Conditions

Fuchs' Endothelial Dystrophy Congenital, Hereditary, and Neonatal Diseases and Abnormalities Corneal Diseases Corneal Dystrophies, Hereditary Corneal Edema Edema Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinikum Düsseldorf, Augenklinik, Düsseldorf, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ODM 5

Device

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 outcomes

  1. Visual acuity (both eyes)

    Time frame: Day 56

    Measurement of uncorrected and best corrected visual acuity (both eyes)

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

TRB Chemedica AG

Industry

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 6, 2015
Registry last updated
Jun 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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