UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Proof of concept trial of ibudilast ophthalmic solution for accommodative asthenopia.
Title of the study (Brief title)	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	Hiroshi Takahashi
Organization	Nippon Medical School Hospital
Division name	Ophthalmology
Address	1-1-5 Sendagi,Bunkyo-ku,Tokyo
TEL	03-3822-2131
Email	tash@nms.ac.jp

Public contact
Name of contact person	Tomonaga Takase
Organization	Nippon Medical School Hospital
Division name	IRB
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

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 05 Month 29 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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