UMIN-CTR Clinical Trial

Basic information
Public title	Quantitative assessment of periocular changes in the eyes treated by glaucoma drops
Acronym	Quantitative assessment of periocular changes in the eyes treated by glaucoma drops
Scientific Title	Quantitative assessment of periocular changes in the eyes treated by glaucoma drops
Scientific Title:Acronym	Quantitative assessment of periocular changes in the eyes treated by glaucoma drops
Region	Japan

Condition
Condition	glaucoma
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess quantitatively the changes in the eye treated by glaucoma drops
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The change in the interpupillary distance 3 months after continual instillation of glaucoma drops in glaucoma patients
Key secondary outcomes	The change in the interpupillary distance 1 and 6 months after continual instillation of glaucoma drops in glaucoma patients Visual acuity, Intra ocular pressure, exophthalmos

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Glaucoma patients who need treatment with eye drops
Key exclusion criteria	the use of topical or systemic steroid or nonsteroidal anti-inflammatory drugs; intraocular, ocular surface, eyelid, or periocular surgeries during the observation period; and a history of disorders that might have affected the ocular position including strabismus, abnormal thyroid function, and central nervous system dysfunction.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Takayuki Middle name Last name Kamiya
Organization	Asahikawa Medical University
Division name	Ophthalmology
Zip code	078-8510
Address	Midorigaoka hibachi 2-1-1-1, Asahikawa 078-8510, Japan
TEL	0166-65-2111
Email	t-kamiya@asahikawa-med.ac.jp

Public contact
Name of contact person	1st name Takayuki Middle name Last name Kamiya
Organization	Asahikawa Medical University
Division name	Ophthalmology
Zip code	078-8510
Address	Midorigaoka hibachi 2-1-1-1, Asahikawa 078-8510, Japan
TEL	0166-65-2111
Homepage URL
Email	t-kamiya@asahikawa-med.ac.jp

Sponsor
Institute	Asahikawa Medical University
Institute
Department

Funding Source
Organization	Japan Society For The Promotion of Science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	Jichi Medical University Asahikawa Eye Clinic Engaru Yamaguchi Eye Clinic Konnno Suguru Eye Clinic Wakkanai City Hospital Nemuro City Hospital Nayoro City General Hospital Yakumo General Hospital Engaru-Kosei General Hospital Shibetsu City Hospital Kouiki Monbetsu Hospital Bihoro Chouritsu Kokuminkenkouhoken Hospital Okubo Eye Clinic JCHO Tokyo Shinjuku Medical Center Takahashi Eye Clinic Hara Eye Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Asahikawa Medical Univesity Research Ethics Committee
Address	Midorigaoka hibachi 2-1-1-1, Asahikawa 078-8510, Japan
Tel	0166-68-2297
Email	rs-kk.g@asahikawa-med.ac.jp

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	2020 Year 04 Month 10 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	Open public recruiting
Date of protocol fixation	2019 Year 10 Month 25 Day
Date of IRB	2020 Year 02 Month 25 Day
Anticipated trial start date	2020 Year 02 Month 25 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	none

Management information
Registered date	2020 Year 04 Month 07 Day
Last modified on	2020 Year 04 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045592