UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023722 |
|---|---|
| Receipt number | R000027326 |
| Scientific Title | Correlation between the change of the ocular surface and the corneal sensory nerve disorder in patients receiving glaucoma therapy drugs. |
| Date of disclosure of the study information | 2016/09/01 |
| Last modified on | 2016/11/17 15:41:17 |
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Basic information
Public title
Correlation between the change of the
ocular surface and the corneal
sensory nerve disorder in patients
receiving glaucoma therapy drugs.
Acronym
Corneal sensory neuropathy in
patients receiving glaucoma therapy
drugs.
Scientific Title
Correlation between the change of the
ocular surface and the corneal
sensory nerve disorder in patients
receiving glaucoma therapy drugs.
Scientific Title:Acronym
Corneal sensory neuropathy in
patients receiving glaucoma therapy
drugs.
Region
| Japan |
Condition
Condition
glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to
observe correlation between the
change of the ocular surface and the
corneal sensory nerve disorder in
patients receiving glaucoma therapy
drugs.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate differences in long nerve fiber density (LNFD) of
corneal parameters between
glaucoma patients and controls
using in vivo confocal microscopy.
Glaucoma patients are sub-grouped according to the period of usage of eye drops.
Key secondary outcomes
corneal sensitivity, epithelial staining, tear volume, etc.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Primary open angle glaucoma or ocular hypertension.
2)Patients have been treated with prostaglandine analogs monotherapy.
Key exclusion criteria
1) Any active ocular disease.
2) Subjects unable to tolerate HRTII-RCM.
3) Previous ocular surgery orlaser treatment
4)Patients whom doctor judged to be ineligible for this study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Shiraishi |
Organization
Ehime University
Division name
Ophthalmology
Zip code
Address
Shizukawa, Toon, Ehime, Japan
TEL
089-960-5361
shiraia@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Xiaodong Zheng |
Organization
Ehime University
Division name
Ophthalmology
Zip code
Address
Shizukawa, Toon, Ehime, Japan
TEL
089-960-5361
Homepage URL
zheng.xiaodong401@gmail.com
Sponsor or person
Institute
Department of Ophthalmology, Ehime
University
Institute
Department
Personal name
Funding Source
Organization
Senju Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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
愛媛大学医学部附属病院（愛媛県）、南松山病院（愛媛県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Date of protocol fixation
| 2016 | Year | 05 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observed research.
This study is evaluated changes of
corneal parameters using confocal
microscopy and ocular surface in
treated glaucoma patients.
Management information
Registered date
| 2016 | Year | 08 | Month | 23 | Day |
Last modified on
| 2016 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027326
