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

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ClinicalTrials.gov Identifier: NCT02746848
Recruitment Status : Completed
First Posted : April 21, 2016
Last Update Posted : April 21, 2016
Sponsor:
Information provided by (Responsible Party):
Royan Institute

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
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 : June 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. corneal defect size [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 24 hours ]
    Evaluation of any presence of pain in treated eye after procedure based on side effect questionnaire that fill with patients.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02746848


Sponsors and Collaborators
Royan Institute
Investigators
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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

Additional Information:
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Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT02746848     History of Changes
Other Study ID Numbers: Royan-Eye-003
First Posted: April 21, 2016    Key Record Dates
Last Update Posted: April 21, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Royan Institute:
cornea epithelium healing Amniotic Membrane Eye Drop
Additional relevant MeSH terms:
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Corneal Injuries
Corneal Diseases
Eye Diseases
Eye Injuries
Facial Injuries
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Wounds and Injuries
Ophthalmic Solutions
Pharmaceutical Solutions