Phase 1 Study to Evaluate the Safety and Tolerability of EO1404 in the Treatment of Corneal Edema (NCT04191629) | Clinical Trial Compass
UnknownPhase 1
Phase 1 Study to Evaluate the Safety and Tolerability of EO1404 in the Treatment of Corneal Edema
Mexico35 participantsStarted 2016-05-04
Plain-language summary
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.
Who can participate
Age range21 Years
SexALL
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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.
✓. 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
✕. Other corneal disease, including active or prior herpetic ocular infection; active inflammation; corneal scarring from trauma, burns, or infection; or band keratopathy.
✕. Visual acuity in the fellow eye is worse than 20/200.
✕. Anterior chamber intraocular lens.
✕. Subject requires topical, intravenous or oral acyclovir and/or related products during study duration
✕. History of vitrectomy.
✕. History of refractive surgery.
✕. Macular disease that in the investigator and/or sponsor's opinion would limit the ability of the subject to demonstrate improvement in BCVA.