Eye Drops for Early Morning-Associated Corneal Swelling of the Cornea (EDEMAS)

July 14, 2020 updated by: Katrin Wacker, MD, University Eye Hospital, Freiburg

Efficacy of Hyperosmolar Eye Drops in Diurnal Corneal Edema in Fuchs Endothelial Dystrophy: a Double Blind Randomized Controlled Trial

This study evaluates the efficacy of hyperosmolar eye drops on early morning edema of the cornea in patients with Fuchs' endothelial corneal dystrophy (FECD). Each participant will receive hyperosmolar eye drops in one eye and lubricating eye drops in the fellow eye.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hyperosmolar eye drops are lubricating eye drops with 5% of sodium chloride. Hyperosmolar eye drops are thought to temporarily deswell the cornea.

During morning hours, patients with Fuchs' endothelial corneal dystrophy (FECD) typically report poor vision and disturbing glare because of corneal edema. To improve vision in advanced stages of the disease, corneal endothelial transplantation has become the treatment of choice. Many patients with Fuchs' endothelial corneal dystrophy (FECD) use hyperosmolar eye drops before transplantation. At present, it is unclear, how much hyperosmolar eye drops help reducing corneal edema in Fuchs' endothelial corneal dystrophy (FECD). Based on our previous work that determined the amount of additional corneal edema in the morning in patients with Fuchs' endothelial corneal dystrophy (FECD), the investigators will assess if hyperosmolar eye drops speed up the deswelling process.

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Wuerttemberg
      • Freiburg, Baden-Wuerttemberg, Germany, 79106
        • Medical Center - University of Freiburg, Eye Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of advanced Fuchs' endothelial corneal dystrophy (FECD)
  • Indication for corneal endothelial transplantation (Descemet Membrane Endothelial Keratoplasty - DMEK)
  • Must be able to speak and understand German or English.

Exclusion Criteria:

  • Other corneal diseases (i.e. epithelial defects except for bullae caused by Fuchs' endothelial corneal dystrophy (FECD), corneal scars, postoperative / bullous keratopathy, corneal degenerations / dystrophies, corneal inflammation / infection)
  • Regular use of drugs potentially affecting the cornea (i.e. amiodarone, chloroquine, triptan, isotretinoin, constant use of antihistamines, use of contact lenses in past four weeks, anesthetic eye drops, corticosteroid eye drops, antibiotic eye drops in past four weeks, glaucoma drops, hyperosmolar eye drops within the past 24 hours)
  • Systemic diseases that affect the cornea (e.g. connective tissue disease, complicated diabetes mellitus)
  • Lack of fixation during corneal tomography

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hyperosmolar Eye Drops
5% sodium chloride eye drops with 0,15% hyaluronic acid; one drop after waking up and one drop 30 min later on study day; investigator administered
Other: Hyperosmolar eye drops
Application of one preservative-free hyperosmolar eye drop, when waking up and one eye drop 30 min later to one eye by the investigators
Other Names:
  • ODM 5 (CE0459)
Placebo Comparator: Lubricating Eye Drops
Lubricating eye drops with 0,15% hyaluronic acid; one drop after waking up and one drop 30 min later on study day; investigator administered
Other: Placebo
Application of one preservative-free lubricating eye drop, when waking up and one eye drop 30 min later to the fellow eye by the investigators
Other Names:
  • Placebo (for hyperosmolar eye drops)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in corneal thickness
Time Frame: Between eye opening in the morning (7 am; Hour 0) and 1 hour later (Hour 1)
Tomography to determine the thickness of the cornea
Between eye opening in the morning (7 am; Hour 0) and 1 hour later (Hour 1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in corneal thickness over time
Time Frame: Over the first 4 hours after eye opening (Hour 0 to Hour 4) and at presumed steady-state in the afternoon (Hour 9)
Tomography to determine the thickness of the cornea
Over the first 4 hours after eye opening (Hour 0 to Hour 4) and at presumed steady-state in the afternoon (Hour 9)
Change in corneal backscatter over time
Time Frame: Over the first 4 hours after eye opening (Hour 0 to Hour 4) and at presumed steady-state in the afternoon (Hour 9)
Tomography to determine corneal backscatter
Over the first 4 hours after eye opening (Hour 0 to Hour 4) and at presumed steady-state in the afternoon (Hour 9)
Change in forward scatter over time
Time Frame: Over the first 4 hours after eye opening (Hour 0 to Hour 4) and at presumed steady-state in the afternoon (Hour 9)
Stray light meter measurement to determine the forward scatter
Over the first 4 hours after eye opening (Hour 0 to Hour 4) and at presumed steady-state in the afternoon (Hour 9)
Change in visual acuity over time
Time Frame: Over the first 4 hours after eye opening (Hour 0 to Hour 4) and at presumed steady-state in the afternoon (Hour 9)
Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts to determine visual acuity
Over the first 4 hours after eye opening (Hour 0 to Hour 4) and at presumed steady-state in the afternoon (Hour 9)
Change in subjective visual acuity
Time Frame: Over the first 4 hours after eye opening (Hour 0 to Hour 4) and at presumed steady-state in the afternoon (Hour 9)
Question on presumed change of vision
Over the first 4 hours after eye opening (Hour 0 to Hour 4) and at presumed steady-state in the afternoon (Hour 9)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Eye Hospital, Freiburg

Investigators

  • Principal Investigator: Katrin Wacker, MD, University of Freiburg, Eye Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2019

Primary Completion (Actual)

June 25, 2020

Study Completion (Actual)

June 25, 2020

Study Registration Dates

First Submitted

October 23, 2019

First Submitted That Met QC Criteria

October 24, 2019

First Posted (Actual)

October 25, 2019

Study Record Updates

Last Update Posted (Actual)

July 15, 2020

Last Update Submitted That Met QC Criteria

July 14, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ETK 366/19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Fuchs' Endothelial Dystrophy

Clinical Trials on Hyperosmolar eye drops

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Togo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe