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

NCT02332109 | Completed

• 1 other identifier: ODM5FDE-PMCF-DE-2015-01
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 4

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.

Conditions

Fuchs' Endothelial Dystrophy; Corneal Edema

Keywords

Fuchs endothelial dystrophy; oedema; sodium chloride; hyaluronan; sodium hyaluronate

Outcome Measures

Primary Outcomes (1)

• Visual acuity (both eyes)

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

  Day 56

Secondary Outcomes (5)

• Corneal thickness

  Day 0, day 28 and day 56

• Visual acuity (both eyes)

  Day 0 and day 28

• Contrast perception (Measurement of contrast values (both eyes))

  Day 0, day 28 and day 56

• Subjective ocular complaints and symptoms (11-point Likert scale)

  Day 0, day 28 and day 56

• Safety parameter (Adverse events)

  Day 0, day 28 and day 56

Study Arms (1)

ODM 5-group

Device: ODM 5

Interventions

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.

ODM 5-group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Presence of corneal oedema caused by Fuchs' endothelial dystrophy

You may not qualify if:

• Contact lens wear
• Hypersensitivity to one of the ODM 5 components

Sponsors & Collaborators

• TRB Chemedica AG: lead

Study Sites (4)

Universitätsklinikum Düsseldorf, Augenklinik

Düsseldorf, 40225, Germany

Location

Praxis Dr. Thomas Kaercher

Heidelberg, 69121, Germany

Location

Universitätsklinikum Magdeburg A.ö.R., Universitätsaugenklinik

Magdeburg, 39120, Germany

Location

Augenklinik der Ludwig-Maximilians-Universität (LMU), Klinikum der Universität München

München, 80336, Germany

Location

MeSH Terms

Conditions

Fuchs' Endothelial Dystrophy; Corneal Edema; Edema

Condition Hierarchy (Ancestors)

Corneal Dystrophies, Hereditary; Corneal Diseases; Eye Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2014
• First Posted: January 6, 2015
• Study Start: September 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: June 7, 2016

Record last verified: 2016-06

Locations

DE (4)