UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006831 |
|---|---|
| Receipt number | 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 16:37:11 |
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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
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
yoshi@med.u-ryukyu.ac.jp
Sponsor or person
Institute
Hospital, University of the Ryukyus
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008084
