UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005084 |
|---|---|
| Receipt number | R000006046 |
| Scientific Title | The incidence of deepening of upper eyelid sulcus (DUES) caused by prostaglandin (PG) analogues |
| Date of disclosure of the study information | 2011/02/19 |
| Last modified on | 2012/08/15 16:05:06 |
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Basic information
Public title
The incidence of deepening of upper eyelid sulcus (DUES) caused by prostaglandin (PG) analogues
Acronym
Relationship between PG analogues and the incidence of deepening of upper eyelid sulcus (DUES)
Scientific Title
The incidence of deepening of upper eyelid sulcus (DUES) caused by prostaglandin (PG) analogues
Scientific Title:Acronym
Relationship between PG analogues and the incidence of deepening of upper eyelid sulcus (DUES)
Region
| Japan |
Condition
Condition
Patients with open angle glaucoma (OAG)
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The deepening of upper eyelid sulcus (DUES) associated with the use of prostaglandin (PG) analogues has been reported as a new side effect, but its frequency of occurrence has been unknown. The purpose of this study is to elucidate the rate of DUES induced by PG analogues associated with DUES.
Basic objectives2
Others
Basic objectives -Others
The second purpose of this study is to elucidate the background factors associated with DUES.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The change of upper eyelid sulcus, IOP, Subjective symptom of DUES
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The subjects of the current study included the patients with open angle glaucoma (OAG) who were required further intraocular pressure (IOP) reduction.
PG analogue was newly started or switched to another PG analogue in both eyes.
We have taken their facial photographs, measured IOP, and asked their subjective symptom of DUES, at start time (switch time), and followed up for several months.
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with open angle glaucoma (OAG)
Key exclusion criteria
Treated or treating ocular or systemic diseases,Past history of ocular surgery
Allergy for PG analogues,Wearing contact lenses during the study,Participation in other clinical researches recently,Using other glaucoma drugs except PG analogues,
Using steroid drugs topically or systemically
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Aihara |
Organization
University of Tokyo, Faculty of Medicine
Division name
Department of Ophthalmology
Zip code
Address
7-3-1 Hongo Bunkyo-ku Tokyo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Rei Sakata |
Organization
Tokyo Metropolitan Geriatric Hospital
Division name
Department of Ophthalmology
Zip code
Address
35-2 Sakaecho Itabashi-ku, Tokyo, 173-0015, Japan
TEL
03-3964-1141
Homepage URL
Sponsor or person
Institute
Department of Ophthalmology, University of Tokyo, Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Ophthalmology, University of Tokyo, Faculty of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
四谷しらと眼科（東京都）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 02 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2009 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2013 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 02 | Month | 15 | Day |
Last modified on
| 2012 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006046
