UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051314 |
|---|---|
| Receipt number | R000058531 |
| Scientific Title | Assessment of dry eye and blink exercise outcome |
| Date of disclosure of the study information | 2023/10/15 |
| Last modified on | 2023/06/10 14:12:34 |
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Basic information
Public title
blink exercise and dry eye
Acronym
BEDE
Scientific Title
Assessment of dry eye and blink exercise outcome
Scientific Title:Acronym
ADEBEO
Region
| Asia(except Japan) |
Condition
Condition
DRY EYE
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess dry eye before and after the blink exercise
Basic objectives2
Others
Basic objectives -Others
to observe the efficacy of methylcellulose (artificial tear) after its recession
to observe the comfort/ status quo with blink exercise
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
ongoing
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
15 subjects will be given the treatment
Interventions/Control_2
15 will be the control with blink exercise
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
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Mild to moderate dry eye
Key exclusion criteria
any ocular or systemic pathology
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Dr.Neeta |
| Middle name | |
| Last name | Mishra |
Organization
Dr D.Y.Patil Institute of Optometry and Visual Sciences, Dr D.Y.Patil university
Division name
optometry
Zip code
411 018
Address
Dr D.Y.Patil Vidyapeeth
TEL
7020960427
neeta_icare@yahoo.com
Public contact
Name of contact person
| 1st name | parvez |
| Middle name | |
| Last name | Shaikh |
Organization
Prime Systems
Division name
proprietor
Zip code
400001
Address
Pune Camp
TEL
8668287793
Homepage URL
prime.systems@yahoo.com
Sponsor or person
Institute
Dr D.Y.Patil Institute of Optometry and Visual Sciences
Institute
Department
Personal name
Funding Source
Organization
nil
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Dr D.Y.Patil Institute of Optometry and Visual Sciences
Address
pimpri ,pune 411018
Tel
02027805706
info.optom@dpu.edu.in
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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 10 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 06 | Month | 10 | Day |
Last modified on
| 2023 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058531
