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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006831
Receipt No. R000008084
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, beta-blocker and CAI
Date of disclosure of the study information 2011/12/09
Last modified on 2015/01/09

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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, beta-blocker 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, beta-blocker 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 study 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, beta-blocker 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 Safety

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, beta-blocker and CAI for more than 2 month (regardless of PG analogues, beta-blocker 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
Middle name
Last name Sawaguchi Shoichi
Organization Hospital, University of the Ryukyus
Division name Department of Ophthalmology
Zip code
Address 207 Uehara, Nishihara-cho, Nakagami-gun, Okinawa prefecture
TEL 098-895-3331
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoshikuni Arakaki
Organization Hospital, University of the Ryukyus
Division name Department of Ophthalmology
Zip code
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
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 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 Completed
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 12 Month 01 Day
Date of closure to data entry
2013 Year 12 Month 01 Day
Date trial data considered complete
2013 Year 12 Month 01 Day
Date analysis concluded
2014 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 12 Month 04 Day
Last modified on
2015 Year 01 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008084

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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