UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of dorzolamide/timolol fixed-dose combination therapy for the patients who need more IOP (trough & peak) reduction under treatment of PG analogues and CAI
Acronym	Effect of dorzolamide hydrochloride/timolol maleate fixed-dose combination on intraocular pressure (trough & peak)
Scientific Title	Evaluation of dorzolamide/timolol fixed-dose combination therapy for the patients who need more IOP (trough & peak) reduction under treatment of PG analogues and CAI
Scientific Title:Acronym	Effect of dorzolamide hydrochloride/timolol maleate fixed-dose combination on intraocular pressure (trough & peak)
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the effect of additional administration of dorzolamide hydrochloride / timolol maleate fixed-dose combination on IOP (trough & peak) in glaucoma patients with uncontrolable IOP under treatmet of PG analogues and CAI
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Change of intraocular pressure (trough & peak) before and after instillation
Key secondary outcomes	Change of intraocular pressure (trough & peak) before and after instillation

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	The subjects take dorzolamide hydrochloride / timolol maleate fixed-dose combination eye drop twice a day for 12weeks.The subjects are scheduled to visit a hospital after 4 and 12 weeks and recieve intraocular pressure (trough & peak) measurement and anterior segments examination.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	"(1) Written informed consent: Patients capable of providing written consent by themselves after full explanation of the study details using a written information to patients. (2) Patients with glaucoma poorly responding to the treatment of prostaglandins and CAI for more than 2 month (regardless of PG analogues and CAI) (3) Patients aged 20 years or older who are capable of providing consent. (4) Males and females.
Key exclusion criteria	"(1) Patients who have undergone an operation (including laser operation) within 3 months before the study. (2) Patients who have difficulty in measuring intraocular pressure using an applanation tonometer. (3) Patients who have difficulty or are unable to undergo fundoscopy (corneal opacity, severe cataract, etc.). (4) Patients expected to require operation for an eye disease during the study period. (5) Patients with serious renal impairment (nephrotic syndrome, acute renal failure, chronic renal failure, etc.) (6) Patients with hepatic function disorder. (7) Patients with bronchial asthma or its history. (8) Patients with bronchospasm or serious chronic obstructive pulmonary disease. (9) Patients with cardiac failure, sinus bradycardia, atrioventricular block (second and third degrees), or cardiogenic shock. (10) Patients with right cardiac failure due to pulmonary hypertension. (11) Patients with congestive cardiac failure. (12) Patients with diabetic ketoacidosis and/or metabolic acidosis. (13) Patients with poorly controlled diabetes mellitus. (14) Patients with a anamnestic history of hypersensitivity to any ingredients of the investigational product. (15)Patients who has received administration of the adrenocortical steroid agent (Skin local administration other than an eye circumference part is good). (16) During a pregnant woman, the nursing or a patient with possibility becoming pregnant. (17) Patients whom it was judged a doctor not to be suitable as an object of the study.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Shoichi Middle name Last name Sawaguchi
Organization	Hospital, University of the Ryukyus
Division name	Department of Ophthalmology
Zip code	9030125
Address	207 Uehara, Nishihara-cho, Nakagami-gun, Okinawa prefecture
TEL	09094054480
Email	sshoichi@med.u-ryukyu.ac.jp

Public contact
Name of contact person	1st name Yoshikuni Middle name Last name Arakaki
Organization	Hospital, University of the Ryukyus
Division name	Department of Ophthalmology
Zip code	903-0125
Address	207 Uehara, Nishihara-cho, Nakagami-gun, Okinawa prefecture
TEL	098-895-3331
Homepage URL
Email	yoshi@med.u-ryukyu.ac.jp

Sponsor
Institute	Hospital, University of the Ryukyus
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	University of the Ryukyus
Address	1 Senbaru, Nishihara-cho, Nakagami-gun, Okinawa prefecture
Tel	0988958016
Email	knknkyu@to.jim.u-ryukyu.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	"山形大学医学部附属病院　眼科 愛媛大学医学部附属病院　眼科"

Other administrative information
Date of disclosure of the study information	2011 Year 12 Month 09 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	No longer recruiting
Date of protocol fixation	2010 Year 10 Month 10 Day
Date of IRB
Anticipated trial start date	2011 Year 03 Month 01 Day
Last follow-up date	2012 Year 09 Month 01 Day
Date of closure to data entry	2012 Year 12 Month 01 Day
Date trial data considered complete	2013 Year 12 Month 01 Day
Date analysis concluded	2014 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date	2011 Year 12 Month 04 Day
Last modified on	2019 Year 06 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008083