UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014695 |
|---|---|
| Receipt number | 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 16:16:28 |
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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
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
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
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
clinicaltrial@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School Ophthalmology
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017081
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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