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

• Sponsor: Royan Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT02746848
• Collaborator: (none)
• Enrollment: 20
• Arm: 1
• Duration (Months): 17

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Cornea Injury	Biological: Amniotic Membrane Extract Eye Drop	Phase 1/Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation the Effect of Amniotic Membrane Extract Eye Drop (AMEED) on Human Corneal Epithelium Healing (Phase I and II Clinical Trial)
• Study Start Date: Jun 1, 2014
• Actual Primary Completion Date: May 1, 2015
• Actual Study Completion Date: Nov 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patients with cornea injury Patients with cornea injury who received healing Amniotic Membrane Extract Eye Drop.	Biological: Amniotic Membrane Extract Eye Drop; Amniotic Membrane Extract use as eye drop for patients with corneal injury.

Outcome Measures

Primary Outcome Measures

1. corneal defect size [12 months]

   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).

Secondary Outcome Measures

1. Eye Discharge [1 week]

   Evaluation the presence of any abnormal discharge from treated eye after procedure based on side effect questionnaire that fill with patients.

2. pain [24 hours]

   Evaluation of any presence of pain in treated eye after procedure based on side effect questionnaire that fill with patients.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Royan Institute

Investigators

• Study Chair: Hamid Gourabi, PhD, Head of Royan Institute
• Study Director: Marzieh Ebrahimi, PhD, Department of Regenerative Biomedicine at Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
• Study Director: Khosro Jadidi, MD, Bina Hospital, Research & Education Center, Tehran, Iran
• Principal Investigator: Fatemeh Doostmohammadi, MD, Bina Hospital, Research & Education Center, Tehran, Iran

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Royan Institute
• ClinicalTrials.gov Identifier: NCT02746848
• Other Study ID Numbers: Royan-Eye-003
• First Posted: Apr 21, 2016
• Last Update Posted: Apr 21, 2016
• Last Verified: Jan 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Royan Institute: cornea epithelium healing Amniotic Membrane Eye Drop
• Additional relevant MeSH terms: Corneal Injuries; Ophthalmic Solutions

Study Results

No Results Posted as of Apr 21, 2016