UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017695 |
|---|---|
| Receipt number | R000020508 |
| Scientific Title | Oxybuprocaine for apraxia of lid opening in Parkinson's disease |
| Date of disclosure of the study information | 2015/05/27 |
| Last modified on | 2018/08/09 05:33:43 |
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Basic information
Public title
Oxybuprocaine for apraxia of lid opening in Parkinson's disease
Acronym
Oxybuprocain for ALO
Scientific Title
Oxybuprocaine for apraxia of lid opening in Parkinson's disease
Scientific Title:Acronym
Oxybuprocain for ALO
Region
| Japan |
Condition
Condition
apraxia of lid opening in Parkinson's disease
Classification by specialty
| Neurology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of 0.4% oxybuprocaine hydrochloride, a short acting corneal anesthetic, on apraxia of lid opening (ALO) in Parkinson's disease (PD).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change of "complete opening time (COT) after 10-second eye closure" (at 13 minutes after eye drops from baseline)
Key secondary outcomes
The percentage change of COT from baseline
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Double blind -all involved 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
Arm 1 intervention consisted of 4%oxybuprocaine eye drop treatment, washout for 24 hours or more, and a saline eye drop treatment
Interventions/Control_2
Arm 2 intervention consisted of saline eye drop treatment, a washout period, and an oxybuprocaine treatment
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
PD patients with ALO.
The ALO criteria were the following: 1) transitory inability to initiate lid opening; 2) no findings of ongoing orbicularis oculi contractions, such as lowering of the brows beneath the superior orbital margins; 3) vigorous frontalis contraction during the period of inability to raise eyelids; and 4) no ocular motor or ocular sympathetic nerve dysfunction or ocular myopathy.
Key exclusion criteria
1) corneal disease such as keratitis, corneal erosion, or ulcers; 2) treatment with botulinum toxin A during the previous 4 months; 3) hypersensitivity to oxybuprocaine hydrochloride; and 4) baseline complete opening time (COT) < 1 second.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideyuki Sawada |
Organization
Utano National Hospital, National Hospital Organization
Division name
Clinical Research Center
Zip code
Address
8 Ondoyama-cho, Narutaki, Ukyoku, Kyoto
TEL
81-75-461-5121
sawada@unh.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayuki Kohsaka |
Organization
Utano National Hospital, National Hospital Organization
Division name
Clinical Research Center
Zip code
Address
8 Ondoyama-cho, Narutaki, Ukyoku, Kyoto
TEL
81-75-461-5121
Homepage URL
kousaka@unh.hosp.go.jp
Sponsor or person
Institute
Utano National Hospital, National Hospital Organization
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
Organization
Division
Category of Funding 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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/abs/10.1002/mds.27243
Number of participants that the trial has enrolled
Results
COT reduced from 3.2 6 2.0 seconds (mean 6 standard deviation) at baseline to 1.7 6 0.8 seconds at 13 minutes in the oxybuprocaine treatment (Supporting Information Video S1) and from 2.5 6 2.4 seconds to 2.6 6 1.6 seconds in the saline treatment.
COT was significantly improved with oxybuprocaine treatment when compared with saline treatment (P 5 .02; Fig.1A). The effect of oxybuprocaine appeared within 4 minutes and remained for at least 13 minutes (Fig. 1B). COT was significantly
shorter with oxybuprocaine treatment than with saline treatment (P 5 .0008). There were no adverse effects.
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
| 2012 | Year | 09 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | 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
Management information
Registered date
| 2015 | Year | 05 | Month | 27 | Day |
Last modified on
| 2018 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020508
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
