UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028494
Receipt number R000032576
Scientific Title A phase III comparative study to evaluate the efficacy and safety of SJP-0125 versus brinzolamide in patients with primary open-angle glaucoma or ocular hypertension
Date of disclosure of the study information 2017/09/16
Last modified on 2019/02/04 09:48:39

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Basic information

Public title

A phase III comparative study to evaluate the efficacy and safety of SJP-0125 versus brinzolamide in patients with primary open-angle glaucoma or ocular hypertension

Acronym

A comparative study to evaluate the efficacy and safety of SJP-0125 versus brinzolamide in patients with primary open-angle glaucoma or ocular hypertension

Scientific Title

A phase III comparative study to evaluate the efficacy and safety of SJP-0125 versus brinzolamide in patients with primary open-angle glaucoma or ocular hypertension

Scientific Title:Acronym

A comparative study to evaluate the efficacy and safety of SJP-0125 versus brinzolamide in patients with primary open-angle glaucoma or ocular hypertension

Region

Japan


Condition

Condition

Primary open-angle glaucoma (broad definition) or ocular hypertension

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy (intraocular pressure reduction) and safety of twice-daily dosed SJP-0125 for 4 weeks compared to 1% brinzolamide ophthalmic solution in patients with primary open-angle glaucoma (broad definition) or ocular hypertension and to confirm if SJP-0125 and concurrent administration of 0.1% brimonidine tartrate and 1% brinzolamide ophthalmic solution as a reference arm have the same efficacy and safety profile.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Changes in IOP (hour 2) from the start day of the treatment period at Week 4

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

One drop of 1% brinzolamide ophthalmic solution is instilled into each eye twice-daily (in the morning and in the evening) for 4 weeks, and then one drop of SJP-0125 is instilled into each eye twice-daily (in the morning and in the evening) for 4 weeks.

Interventions/Control_2

One drop of 1% brinzolamide ophthalmic solution is instilled into each eye twice-daily (in the morning and in the evening) for 4 weeks, and then one drop of 0.1% brimonidine tartrate is instilled into each eye twice-daily (in the morning and in the evening) for 4 weeks.

Interventions/Control_3

One drop of 1% brinzolamide ophthalmic solution is instilled into each eye twice-daily (in the morning and in the evening) for 4 weeks, and then one drop of 0.1% brimonidine tartrate is instilled into each eye twice-daily (in the morning and in the evening) for 4 weeks.

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 obtained after adequate explanation on participating the study
2) Japanese male or female outpatient, 20 years of age or older
3) Patients with primary open-angle glaucoma (broad definition) or ocular hypertension
4) Required ophthalmic solution for IOP-lowering treatment
5) IOP =< 31.0 mmHg
6) Best corrected visual acuity >= 0.3

Key exclusion criteria

1) Prior ocular instillation of SJP-0125
2) History of surgical intervention or laser treatment for glaucoma
3) History of intraocular surgery within past 90 days
4) Anticipated wearing of any contact lenses
5) Intraocular injection, sub-Tenon or subconjunctival injection of a corticosteroid agent within past 180 days
6) Patients who are pregnant, breastfeeding, or potentially pregnant. or who desire to be pregnant or who do not intend to prevent conception from consent to the end of the treatment period
7) Participated in any other clinical trial within past 90 days and received any other investigational drug or plans to participate in any other clinical trial during the study
8) Presence of any active retinal disease which may progress during the study
9) Presence of any active ocular disease other than primary open-angle glaucoma (broad definition) or ocular hypertension
10) Presence of a cancer or a serious systemic disease
11) Presence of any circulatory failure
12) Presence of corneal disorder
13) Presence of serious visual field defect
14) Presence of corneal abnormality which is considered to preclude accurate measurement of IOP by Goldmann applanation tonometer
15) History of corneal transplantation or keratorefractive surgery
16) History of allergy or significant adverse drug reaction to any ingredients of drugs used in this study

Target sample size

376


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Makoto Aihara

Organization

The University of Tokyo

Division name

Department of Ophthalmology, Graduate School of Medicine and Faculty of Medicine

Zip code


Address

7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-8655 Japan

TEL

03-5800-6415

Email

aihara-tky@umin.net


Public contact

Name of contact person

1st name
Middle name
Last name Takuro Sekiya

Organization

Senju Pharmaceutical Co.,Ltd.

Division name

Clinical Development

Zip code


Address

3-1-9, Kawara-machi, Chuo-ku, Osaka, Japan

TEL

06-6201-9605

Homepage URL


Email

t-sekiya@senju.co.jp


Sponsor or person

Institute

Senju Pharmaceutical Co.,Ltd.

Institute

Department

Personal name



Funding Source

Organization

Senju Pharmaceutical Co.,Ltd.

Organization

Division

Category of Funding Organization

Profit organization

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



Other administrative information

Date of disclosure of the study information

2017 Year 09 Month 16 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

2017 Year 06 Month 29 Day

Date of IRB


Anticipated trial start date

2017 Year 09 Month 16 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

2017 Year 08 Month 02 Day

Last modified on

2019 Year 02 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032576


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name