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Recruitment status Completed
Unique ID issued by UMIN UMIN000014695
Receipt No. R000017081
Scientific Title Proof of concept trial of ibudilast ophthalmic solution for accommodative asthenopia.
Date of disclosure of the study information 2014/07/30
Last modified on 2018/12/17

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Basic information
Public title Proof of concept trial of ibudilast ophthalmic solution for accommodative asthenopia.
Acronym Proof of concept trial of ibudilast ophthalmic solution for accommodative asthenopia.
Scientific Title Proof of concept trial of ibudilast ophthalmic solution for accommodative asthenopia.
Scientific Title:Acronym Proof of concept trial of ibudilast ophthalmic solution for accommodative asthenopia.
Region
Japan

Condition
Condition Accommodative asthenopia
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the efficacy and safety of 0.01% ibudilas ophthalmic solution and those of 0.02% cyanocobalamin ophthalmic solution on accommodative asthenopia
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Changes in the frequency of occurrence of HFC in accommodative microfluctuation
Key secondary outcomes Subjective symptoms (questionnaire NRS)
Degree of refraction, Vision Regulation
Accommodative response
Effect on tear secretion

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 0.01% ibudilas ophthalmic solution :Apply 1 drop at a time, 4 times daily, for 4 weeks
Interventions/Control_2 0.02% cyanocobalamin ophthalmic solution: Apply 1 drop at a time, 4 times daily, for 4 weeks
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
39 years-old >=
Gender Male and Female
Key inclusion criteria 1) The patients who consent to participate in this study by informed concent
2)The patient over 20 and under40 years of age
3) Outpatient
4) The patients who do not require a frequent change of glasses or contact lenses during the study period and corrected visual acuity above 0.8 and refraction below -3.0D.
5) Patients with symptoms of asthenopia, and frequent high-frequency components in the vicinity of resting state of accommodation in accomodative microfluctuation of objective remark
Key exclusion criteria 1) Patients with a history of allergy to experimental drug
2) Astigmatism patients over -2.0D
3) Patients with punctal plug as a treatment for dry eye

4) Patients with ocular deviation , ocular inflammation not including dry eye (including ocular allergy) , ocular infection, glaucoma or diabetes that affect the efficacy evaluation
5) Patients with corneal epithelium disorder over moderate
6) Patients who underwent cataract surgery or refractive surgery
7) Patients who underwent ophthalmic surgery within 3 months
8)Patients using eye drops except the dry eye syndrome therapeutic drug.
9) Patients with abnormalities evident on the refractive response, such as presbyopia, etc.
10) Patients with systemic disease that may affect the safety or effectiveness of the drug evaluation
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Takahashi
Organization Nippon Medical School Hospital
Division name Ophthalmology
Zip code
Address 1-1-5 Sendagi,Bunkyo-ku,Tokyo
TEL 03-3822-2131
Email tash@nms.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomonaga Takase
Organization Nippon Medical School Hospital
Division name IRB
Zip code
Address 1-1-5 Sendagi,Bunkyo-ku,Tokyo
TEL 03-3822-2131
Homepage URL
Email clinicaltrial@nms.ac.jp

Sponsor
Institute Nippon Medical School Ophthalmology
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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
2014 Year 07 Month 30 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 Completed
Date of protocol fixation
2014 Year 05 Month 29 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 12 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
2014 Year 07 Month 29 Day
Last modified on
2018 Year 12 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017081


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