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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017695
Receipt No. 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

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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
Email 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
Email kousaka@unh.hosp.go.jp

Sponsor
Institute Utano National Hospital, National Hospital Organization
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020508

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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