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

NCT04140422 | Completed DMC

• 1 other identifier: ETK 366/19
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fuchs' Endothelial Dystrophy

Keywords

Corneal edema; Descemet membrane endothelial keratoplasty (DMEK); Hyperosmolar eye drops

Outcome Measures

Primary Outcomes (1)

• Change in corneal thickness

  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 Outcomes (5)

• Change in corneal thickness over time

  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

  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

  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

  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

  Over the first 4 hours after eye opening (Hour 0 to Hour 4) and at presumed steady-state in the afternoon (Hour 9)

Study Arms (2)

Hyperosmolar Eye Drops

EXPERIMENTAL

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

Lubricating Eye Drops

PLACEBO COMPARATOR

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

Interventions

Hyperosmolar eye drops OTHER

Application of one preservative-free hyperosmolar eye drop, when waking up and one eye drop 30 min later to one eye by the investigators

Also known as: ODM 5 (CE0459)

Hyperosmolar Eye Drops

Placebo OTHER

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

Also known as: Placebo (for hyperosmolar eye drops)

Lubricating Eye Drops

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Eye Hospital, Freiburg: lead

Study Sites (1)

Medical Center - University of Freiburg, Eye Hospital

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

Related Publications (4)

• Fritz M, Grewing V, Maier P, Lapp T, Bohringer D, Reinhard T, Wacker K. Diurnal Variation in Corneal Edema in Fuchs Endothelial Corneal Dystrophy. Am J Ophthalmol. 2019 Nov;207:351-355. doi: 10.1016/j.ajo.2019.08.002. Epub 2019 Aug 12.

  PMID: 31415734 BACKGROUND

• Wacker K, Baratz KH, Bourne WM, Patel SV. Patient-Reported Visual Disability in Fuchs' Endothelial Corneal Dystrophy Measured by the Visual Function and Corneal Health Status Instrument. Ophthalmology. 2018 Dec;125(12):1854-1861. doi: 10.1016/j.ophtha.2018.06.018. Epub 2018 Aug 10.

  PMID: 30104038 BACKGROUND

• Wilson SE, Bourne WM. Fuchs' dystrophy. Cornea. 1988;7(1):2-18.

  PMID: 3280235 BACKGROUND

• Zander DB, Bohringer D, Fritz M, Grewing V, Maier PC, Lapp T, Reinhard T, Wacker K. Hyperosmolar Eye Drops for Diurnal Corneal Edema in Fuchs' Endothelial Dystrophy: A Double-Masked, Randomized Controlled Trial. Ophthalmology. 2021 Nov;128(11):1527-1533. doi: 10.1016/j.ophtha.2021.04.015. Epub 2021 Apr 20.

  PMID: 33892048 DERIVED

MeSH Terms

Conditions

Fuchs' Endothelial Dystrophy; Corneal Edema

Condition Hierarchy (Ancestors)

Corneal Dystrophies, Hereditary; Corneal Diseases; Eye Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Katrin Wacker, MD

  University of Freiburg, Eye Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The allocation is done randomly by the hospitals pharmacy. By using identical containers for the hyperosmolar eye drops and the lubricating eye drops participants and medical staff are not able to distinguish both substances.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study uses both eyes of the participant to allow inter- and intraindividual comparisons. One eye will be randomized to be treated with hyperosmolar eye drops, the fellow eye will be treated with lubricating eye drops.

Study Record Dates

• First Submitted: October 23, 2019
• First Posted: October 25, 2019
• Study Start: October 24, 2019
• Primary Completion: June 25, 2020
• Study Completion: June 25, 2020
• Last Updated: July 15, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)