UMIN-CTR Clinical Trial

Basic information
Public title	Clinical outcomes of dry-preserved amniotic membrane allograft transplant for ocular surface disease
Acronym	DAMAT for OSD
Scientific Title	Clinical outcomes of dry-preserved amniotic membrane allograft transplant for ocular surface disease
Scientific Title:Acronym	DAMAT for OSD
Region	Asia(except Japan)

Condition
Condition	Ocular suface disease
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the clinical outcomes of dry-preserved amniotic membrane transplantation in Ocular Surface Diseases
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	1) Rate of retention of dehydrated amniotic membrane/ soft contact lens 2) Pain/Photophobia scale 3) Visual Acuity (BSCVA) 4) External Eye Examination 5) Slit-lamp Examination
Key secondary outcomes	Adverse events

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	single application of dry-preserved amniotic membrane retained by soft contact lenses, Dry-preserved membrane applied once and removed after 2 to 3 week interval
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. ocular surface disease 2. Persistent corneal epithelial defect 3. Thermal/Chemical Burn 4, Corneal ulcer/scar 5, Dry Eye Syndrome 6. Dysfunctional Tear Syndrome 7. Filamentary keratitis
Key exclusion criteria	Subjects were excluded from the study if any of the following criteria was fulfilled, corneal or scleral perforation or impending perforation, subjects with recent or active infection, subjects not able to understand the character and individual consequences of the investigation, and participation in other clinical research within the last 8 weeks.
Target sample size	33

Research contact person
Name of lead principal investigator	1st name Harvey Middle name Siy Last name Uy
Organization	Peregrine Eye and Laser Institute
Division name	Research Division
Zip code	1209
Address	5F Morning Star Center, 347 Gil Puyat Avenue, Bel Air, Makati City, Philippines
TEL	63288900115
Email	harveyuy@yahoo.com

Public contact
Name of contact person	1st name Angeline Middle name Last name Chiong
Organization	Peregrine Eye and Laser Institute
Division name	Research Section
Zip code	1209
Address	5F Morning Star Center, 347 Gil Puyat Avenue, Bel Air, Makati City, Philippines
TEL	63288900115
Homepage URL	http://peregrineeye.com
Email	angeline.chiong@peregrineeye.com

Sponsor
Institute	Peregrine Eye and Laser Institute Research Section
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Philippines

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Peregrine Eye and Laser Institute - Institutional Review Board
Address	Peregrine Eye and Laser Institute, 5F Morming Star Center, 347 Gil Puyat Avenue, Bel Air, Makati, Philippines 1209
Tel	63288900115
Email	irb@peregrineeye.com

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	Peregrine Eye and Laser Institute, 5F Morming Star Center, 347 Gil Puyat Avenue, Bel Air, Makati, Philippines 1209

Other administrative information
Date of disclosure of the study information	2021 Year 05 Month 09 Day

Related information
URL releasing protocol	Per request from PI
Publication of results	Unpublished

Result
URL related to results and publications	Not applicable
Number of participants that the trial has enrolled	30
Results	Improved ocular comfort was reported 97%. Mean ocular discomfort score decreased from 3.30 to 1.24 while mean photophobia score decreased from 3.15 to 1.27. Mean LogMAR BCVA improved from 0.42 to 0.25. The AM and SCL remained in position for 94% of eyes. Complete corneal epithelialization was observed in all eyes immediately after SCL removal.
Results date posted	2021 Year 05 Month 09 Day
Results Delayed	Delay expected
Results Delay Reason	Pending publication acceptance
Date of the first journal publication of results
Baseline Characteristics	Methods. Prospective, non-comparative, interventional case series. Thirty-four (34) eyes of 30 patients with ocular surface disease (OSD) variably characterized by tear deficiency, superficial punctate keratopathy (SPK), and corneal epithelial defects
Participant flow	Enrolled eyes underwent ocular surface rehabilitation by DAMAT utilizing processed amniotic membrane (AmnioTek C, ISP Surgical, Boston, MA). The DAM was retained using conventional soft contact lenses (SCL) for 2 to 3 weeks after which the SCL was removed. Patients were followed up 2 months after AM/SCL application.
Adverse events	Eight of 34 (24%) eyes required repeat DAMT after SCL removal due to recurrence of epithelial defects or ocular discomfort. One (3%) eye required AM/SCL reapplication due to spontaneous displacement. One (3%) eye required AM/SCL removal due to intolerable foreign body sensation. No serious adverse reactions related to either AM or SCL were observed.
Outcome measures	Main outcome measures: Ocular discomfort score, photophobia score, best-corrected visual acuity (BCVA), AM/SCL retention, corneal re-epithelialization and quality after SCL removal, reapplication rate and adverse events.
Plan to share IPD	Per request from PI
IPD sharing Plan description	Per request from PI: harveyuy@yahoo.com

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2015 Year 03 Month 11 Day
Date of IRB	2015 Year 12 Month 15 Day
Anticipated trial start date	2018 Year 04 Month 16 Day
Last follow-up date	2018 Year 07 Month 15 Day
Date of closure to data entry	2018 Year 12 Month 01 Day
Date trial data considered complete	2018 Year 12 Month 15 Day
Date analysis concluded	2020 Year 04 Month 15 Day

Other
Other related information

Management information
Registered date	2021 Year 05 Month 09 Day
Last modified on	2021 Year 05 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050412