NCT02746848

Utilization of Amniotic Membrane Extract Eye Drop (AMEED) on Human Corneal Healing

Evaluation the Effect of Amniotic Membrane Extract Eye Drop (AMEED) on Human Corneal Epithelium Healing (Phase I and II Clinical Trial)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Royan Institute · Other Government
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Accepted

Summary

For severe ocular surface diseases, such as chemical and thermal injuries, Stevens-Johnson syndrome (SJS), Band Keratopathy, Corneal Dystrophies, Refractive (PRK-LASEK), corneal surgery and others, it is important that short time treatment with minimal side effect should be considered. This study is a prospective clinical trial to use Amniotic Membrane Extract Eye Drop (AMEED) as a natural substance for acceleration of corneal healing

Detailed description

The cornea is the specific anterior part of eye that is essential for normal vision. The corneal surface is comprised of a unique type of non-keratinized epithelial cell. Corneal epithelium contains transient amplifying cells and post mitotic cells. The limbal stem cells (LSC) are located between limbal cornea and conjunctiva which are main source of corneal epithelium healing in eye injuries. For some corneal disease such as chemical and thermal injuries, Corneal Dystrophies and corneal surgery, treatment in short time is important. AM can modulate corneal epithelium healing by promoting re-epithelialization and migration of limbal stem cell while suppressing stromal inflammation, angiogenesis and scarring. This biological substrate maintain epithelial progenitor cells within the limbal stem cell niche and facilitate ocular surface epithelial renewal. It is well accepted that amniotic membrane Transplantation (AMT) as a temporary patch normally dissolves within 2 weeks. Consequent reapplication of membrane is difficult for the patient. Other studies have been reported that processed AM as a liquid has comparable effect to AMT in treatment of corneal epithelial healing. This study is a prospective clinical trial to use Amniotic Membrane Extract Eye Drop (AMEED) as a natural substance for acceleration of corneal healing.

Conditions

• Cornea Injury

Interventions

Type	Name	Description
BIOLOGICAL	Amniotic Membrane Extract Eye Drop	Amniotic Membrane Extract use as eye drop for patients with corneal injury.

Timeline

• Start date: 2014-06-01
• Primary completion: 2015-05-01
• Completion: 2015-11-01
• First posted: 2016-04-21
• Last updated: 2016-04-21