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

Cornea Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02746848
• Other study ID #: Royan-Eye-003
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 10, 2016
• Last updated: April 18, 2016
• Start date: June 2014
• Est. completion date: November 2015

Study information

• Verified date: January 2016
• Source: Royan Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Patient with corneal epithelium injury

2. Without keratoconus

3. Without cornea scar

4. Without any other lesion of cornea

Exclusion Criteria:

1. Lack of timely referral of patients for examinations

2. Simultaneous use of other drugs that cause impairment of the data

3. Previous cornea surgery

4. Dry eye

5. Glaucoma

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cornea Injury

Intervention

Biological:
• Amniotic Membrane Extract Eye Drop
Amniotic Membrane Extract use as eye drop for patients with corneal injury.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Royan Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	corneal defect size	Evaluation the corneal defect size (millimeter) by microscope after corneal surgery and compare the change of defect size after procedure in compare with base line (before surgery).	12 months	Yes
Secondary	Eye Discharge	Evaluation the presence of any abnormal discharge from treated eye after procedure based on side effect questionnaire that fill with patients.	1 week	Yes
Secondary	pain	Evaluation of any presence of pain in treated eye after procedure based on side effect questionnaire that fill with patients.	24 hours	Yes

External Links

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