UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006410
Receipt number R000007604
Scientific Title The efficacy of alternative regimen with dorzolamide/timolol fixed combination for glaucoma patients with combined use of the three separate components (prostaglandin analogue, beta-blocker and carbonic anhydrase inhibitor): a randomized, crossover trial.
Date of disclosure of the study information 2011/10/01
Last modified on 2011/09/26 21:59:48

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Basic information

Public title

The efficacy of alternative regimen with dorzolamide/timolol fixed combination for glaucoma patients with combined use of the three separate components (prostaglandin analogue, beta-blocker and carbonic anhydrase inhibitor): a randomized, crossover trial.

Acronym

The efficacy of alternative regimen with dorzolamide/timolol fixed combination for glaucoma patients with combined use of the three separate components (prostaglandin analogue, beta-blocker and carbonic anhydrase inhibitor): a randomized, crossover trial.

Scientific Title

The efficacy of alternative regimen with dorzolamide/timolol fixed combination for glaucoma patients with combined use of the three separate components (prostaglandin analogue, beta-blocker and carbonic anhydrase inhibitor): a randomized, crossover trial.

Scientific Title:Acronym

The efficacy of alternative regimen with dorzolamide/timolol fixed combination for glaucoma patients with combined use of the three separate components (prostaglandin analogue, beta-blocker and carbonic anhydrase inhibitor): a randomized, crossover trial.

Region

Japan


Condition

Condition

primary open angle glaucoma
exfoliation glaucoma

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare intraocular pressure-lowering efficacy and safety between fixed combination of timolol/dorzolamide and concurrent administration of timolol(once-daily) + dorzolamide in open-label, randomized crossover test.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Intraocular pressure

Key secondary outcomes

Safety


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Eye drops of fixed combination of timolol/dorzolamide (twice daily) for 4 weeks. Then eye drops of timolol(once daily) and dorzolamide (three times a day) for 4 weeks.

Interventions/Control_2

Eye drops of timolol(once daily) and dorzolamide (three times a day) for 4 weeks. Then eye drops of fixe combination of timolol/dorzolamide (twice 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


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 written information to patients.
(2) Patients with glaucoma inadequately controlled with combined use of prostaglandins (except for Isopropyl Unoprostone), beta-blocker and CAI for more than 2 months (regardless of PG analogues, beta-blocker and CAI).
(3) The level of visual field defect: mean deviation with Humphrey Field Analyzer is less progressive than -15 dB within 6 months before the study.
(4) Visual acuity: better than 0.7 in best corrected visual acuity.
(5) Patients aged 20 years or older who are capable of providing consent.
(6) Males and females.

Key exclusion criteria

(1) Pregnant and lactating women, the women who desired of the pregnancy.
(2) Patients who have difficulty or are unable to undergo fundoscopy ( severe cataract, etc.).
(3) Patients with active external ocular diseases, ocular inflammation or infection.
(4) Patients with any corneal abnormality or other condition preventing reliable applanation tonometry.
(5) Patients with history of refractive surgery, glaucoma surgery (SLT, trabeculotomy, trabeculectomy etc), vitreous surgery or retinal detachment surgery.
(6) Patients with history of surgery for cataract within 3 months before the study.
(7) Patients expected to require operation for an eye disease during the study period.
(8) Patients with serious renal impairment (nephrotic syndrome, acute renal failure, chronic renal failure, etc.)
(9) Patients with hepatic function disorder.
(10) Patients with bronchial asthma or its history.
(11) Patients with bronchospasm or serious chronic obstructive pulmonary disease.
(12) Patients with cardiac failure, sinus bradycardia, atrioventricular block (second and third degrees), or cardiogenic shock.
(13) Patients with right cardiac failure due to pulmonary hypertension.
(14) Patients with congestive cardiac failure.
(15) Patients with diabetic ketoacidosis and/or metabolic acidosis.
(16) Patients with poorly controlled diabetes mellitus.
(17) Patients with a anamnestic history of hypersensitivity to any ingredients
of the investigational product.
(18) Patients who has received administration of the adrenocortical steroid agent (except for local skin administration other than around eyes).
(19) Patients whom doctor judged to be ineligible for this study.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuhisa Sugiyama

Organization

Kanazawa University

Division name

Department of Ophthalmology

Zip code


Address

13-1 Takara-machi, Kanazawa, Ishikawa

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Eiji Murotani

Organization

Kanazawa University

Division name

Department of Ophthalmology

Zip code


Address

13-1 Takara-machi, Kanazawa, Ishikawa

TEL


Homepage URL


Email



Sponsor or person

Institute

Department of Ophthalmology, Kanazawa University

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


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

金沢大学附属病院(石川県)、公立能登総合病院(石川県)、福井県済生会病院(福井県)、福井県立病院(福井県)、市立砺波総合病院(富山県)、富山市民病院(富山県)


Other administrative information

Date of disclosure of the study information

2011 Year 10 Month 01 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

Preinitiation

Date of protocol fixation

2011 Year 09 Month 28 Day

Date of IRB


Anticipated trial start date

2011 Year 10 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2011 Year 09 Month 26 Day

Last modified on

2011 Year 09 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007604


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name