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

Fuchs' Endothelial Dystrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02332109
• Other study ID #: ODM5FDE-PMCF-DE-2015-01
• Status: Completed
• Phase: N/A
• First received: December 19, 2014
• Last updated: June 6, 2016
• Start date: September 2015
• Est. completion date: May 2016

Study information

• Verified date: June 2016
• Source: TRB Chemedica AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Corneal Edema
• Fuchs' Endothelial Dystrophy

Intervention

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.

Locations

Country	Name	City	State
Germany	Universitätsklinikum Düsseldorf, Augenklinik	Düsseldorf
Germany	Praxis Dr. Thomas Kaercher	Heidelberg
Germany	Universitätsklinikum Magdeburg A.ö.R., Universitätsaugenklinik	Magdeburg
Germany	Augenklinik der Ludwig-Maximilians-Universität (LMU), Klinikum der Universität München	München

Sponsors (1)

Lead Sponsor	Collaborator
TRB Chemedica AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity (both eyes)	Measurement of uncorrected and best corrected visual acuity (both eyes)	Day 56	No
Secondary	Corneal thickness	Measurement of central corneal thickness (both eyes)	Day 0, day 28 and day 56	No
Secondary	Visual acuity (both eyes)	Measurement of uncorrected and best corrected visual acuity (both eyes)	Day 0 and day 28	No
Secondary	Contrast perception (Measurement of contrast values (both eyes))	Measurement of contrast values (both eyes)	Day 0, day 28 and day 56	No
Secondary	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	Day 0, day 28 and day 56	No
Secondary	Safety parameter (Adverse events)	Adverse events judged to be unexpected and (possibly) related to ODM 5 will be documented	Day 0, day 28 and day 56	Yes