UMIN-CTR Clinical Trial

Public title

Phase II study of SNJ-2022; An exploration study in patients with primary open angle glaucoma or ocular hypertension

Acronym

An exploration study of SNJ-2022 in patients with primary open angle glaucoma or ocular hypertension

Scientific Title

Phase II study of SNJ-2022; An exploration study in patients with primary open angle glaucoma or ocular hypertension

Scientific Title:Acronym

An exploration study of SNJ-2022 in patients with primary open angle glaucoma or ocular hypertension

Region

Japan

Condition

Primary open-angle glaucoma (POAG) or Ocular hypertension (OH)

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the ocular hypotensive efficacy and safety of SNJ-2022 0.1%, 0.15% or SNJ-2022 vehicle given b.i.d. for 4 weeks in patients with POAG or OH

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Mean change from baseline intraocular pressure (IOP) at last visit (Hour 0 and 2)

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Dose comparison

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

0.1% SNJ-2022 instilled in both eyes, b.i.d. for 4 weeks.

Interventions/Control_2

0.15% SNJ-2022 instilled in both eyes, b.i.d. for 4 weeks.

Interventions/Control_3

Vehicle instilled in both eyes, b.i.d. for 4 weeks.

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1)Patients had POAG or OH
2)Patients who needs the treatment with eye drops in both eyes
3)Patients were likely to be controlled on glaucoma medication
4)IOP (hour 0)
POAG:IOP of >=18.0 mmHg and <= 31.0 mmHg
OH:IOP of >= 22.0 mmHg and <= 31.0 mmHg
5)Best corrected visual acuity of 0.7 or better

Key exclusion criteria

1)Any active ocular disease other than glaucoma or OH
2)Active retinal disease
3)History of keratorefractive surgery, filtering surgery, trabeculotomy in the study eye
4)Ocular surgery within 3 months in the study eye
5)Use of contact lenses
6)Allergy or serious side effect to alpha2-adrenergic agonist
7)Use of alpha-adrenoceptor agonist, alpha-adrenoceptor antagonist, beta-adrenergic agonist, beta-adrenoceptor antagonist, MAO inhibitor, adrenergic-augmenting psychotropic drugs, Central Nervous System Depressant
8)Patient with Impaired liver function, kidney disorder, depression, raynaud disease, thromboangiitis obliterans, orthostatic hypotension, cerebrovascular occlusion, coronary vessel occlusion, compromised circulation of serious cardiovascular disease
9)Women who were pregnant, nursing or who were of childbearing potential, or planning a pregnancy
10)Highly visual field loss
11)Corneal abnormalities that would preclude accurate readings with an applanation tonometer

Target sample size

120

Name of lead principal investigator

1st name
Middle name
Last name	Makoto Araie

Organization

Kanto Central Hospital of the Mutual Aid Association of Public School Teachers

Division name

Director

Zip code

Address

6-25-1, Kamiyoga, Setagaya-ku, Tokyo 158-8531, Japan

TEL

03-3429-1171

Email

araie-tky@umin.net

Name of contact person

1st name
Middle name
Last name	Yoko Minagawa

Organization

Senju Pharmaceutical co.,ltd.

Division name

Clinical Development

Zip code

Address

2-5-8, Hirano-machi, Chuo-ku, Osaka 541-0046, Japan

TEL

06-6201-9605

Homepage URL

Email

yoko_minagawa@senju.co.jp

Institute

Senju Pharmaceutical co.,ltd.

Institute

Department

Personal name

Organization

Senju Pharmaceutical co.,ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

09

Month

28

Day

URL releasing protocol

Publication of results

Published

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

Recruitment status

Completed

Date of protocol fixation

2006

Year

02

Month

01

Day

Date of IRB

Anticipated trial start date

2006

Year

03

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

09

Month

28

Day

Last modified on

2015

Year

09

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022131