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

NCT02332109 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 29

Last updated 2016-06-07

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • TRB Chemedica AG

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02332109 on ClinicalTrials.gov