Status and phase
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Treatments
About
Single center, phase 1 study to evaluate the safety and tolerability of EO1404 in subjects with corneal edema secondary to pseudophakic bullous keratopathy or Fuch's endothelial dystrophy.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Age ≥ 21 years
Pseudophakic with a posterior chamber intraocular lens.
Symptomatic corneal edema associated with endothelial dysfunction which may be secondary to Fuchs corneal dystrophy or pseudophakic bullous keratopathy.
a Symptoms including reduced vision and/or glare, and/or pain; subject may or may not have been on topical therapies such as 5% sodium chloride drops or prednisolone acetate 1% drops.
b ETDRS-best corrected visual acuity worse than 20/63 on Snellen. c Central corneal thickness < 2 mm by ultrasound pachymetry or OCT. d Subject must have progressed far enough in their clinical course to be considered a surgical candidate for full-thickness corneal transplantation or endothelial keratoplasty.
Subject must understand and sign the informed consent. If the subject's vision is impaired to the point where he/she cannot read the informed consent document, the document will be read to the subject in their maternal language.
Subject must be medically able and willing to undergo the protocol-required procedures.
Exclusion criteria
All ocular criteria apply to study eye unless otherwise noted.
Primary purpose
Allocation
Interventional model
Masking
35 participants in 4 patient groups
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Central trial contact
Valeria Sanchez-Huerta, MD
Data sourced from clinicaltrials.gov
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