UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034108
Receipt No. R000035363
Scientific Title The efficacy and safety of Latanoprost ophthalmic solution 0.005% Nitten in Japanese open-angle glaucoma patients
Date of disclosure of the study information 2018/09/17
Last modified on 2018/09/12

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The efficacy and safety of Latanoprost ophthalmic solution 0.005% Nitten in Japanese open-angle glaucoma patients
Acronym The efficacy and safety of Latanoprost ophthalmic solution 0.005% Nitten in Japanese open-angle glaucoma patients
Scientific Title The efficacy and safety of Latanoprost ophthalmic solution 0.005% Nitten in Japanese open-angle glaucoma patients
Scientific Title:Acronym The efficacy and safety of Latanoprost ophthalmic solution 0.005% Nitten in Japanese open-angle glaucoma patients
Region
Japan

Condition
Condition glaucoma
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To Compare the intraocular pressure lowering effect and the effect of the ocular surface between latanoprost Nitten and Xalatan ophthalmic solution in Japanese open-angle glaucoma patients.
Basic objectives2 Others
Basic objectives -Others Since glaucoma is a chronic progressive disease, management is lifelong, thus choices of cheap generic drugs should also be considered. However, evaluation and safety of glaucoma patients have not been established. This is one of the reasons why generic drugs for PG-related drugs are difficult to select.
This time, we planned exploratory parallel group comparison test for Japanese glaucoma patients using 0.005% Xalatan eye drops and 0.005% of latanoprost ophthalmic solution as one of its generic drugs containing sodium benzoate.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Comparison of intraocular pressure lowering effect for 6 months
Key secondary outcomes Time course of conjunctival hyperemia and corneal epithelial disorder for 6 months

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Group A receives the ophthalmic solution of Xalatan for 6 months once every day in both eyes at 21:00 +/- 2 hours.
Interventions/Control_2 Group B receives Latanoprost eye drop "Nittens" for 6 months once every day in both eyes at 21: 00 +/- 2 hours.
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1. Age: > 20 years and < 80 years, gender unquestioned
2. Confirmed diagnosis of open-angle glaucoma (broad sense)
3. The number of glaucoma ophthalmic medications in use shall be limited to one agent (regardless of type)
4. Experience of taking Humphrey visual field
5. Fixation failure, false positive, and false negative rate which are targets for reliability of visual field are all less than 20%
6. The mean deviation (MD) value of the visual field is > -10 dB
7. Spherical equivalent is > -6.0 diopters and corrected visual acuity is > 1.0
Key exclusion criteria 1. With a history of eye surgery including laser
2. Having allergy to prostaglandin related drug
3. Using ophthalmic or internal steroids
4. Oral administration of acetazolamide (Diamox)
5. The contact lenses are scheduled to be used during the test period
6. Persons who judged that the doctor in charge is not appropriate
Target sample size 72

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Aihara
Organization The University of Tokyo Hospital
Division name Department of ophthalmology
Zip code
Address Bunkyo-ku Hongo 7-3-1
TEL 03-3815-5411
Email aihara-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Rei Sakata
Organization The University of Tokyo Hospital
Division name Department of ophthalmology
Zip code
Address Bunkyo-ku Hongo 7-3-1
TEL 03-3815-5411
Homepage URL
Email reisakata-tky@umin.ac.jp

Sponsor
Institute The University of Tokyo Hospital
Institute
Department

Funding Source
Organization The University of Tokyo Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Touto Bunkyo Hospital
Name of secondary funder(s) N/A

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 東京大学病院(東京都)、東都文京病院(東京都)

Other administrative information
Date of disclosure of the study information
2018 Year 09 Month 17 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
2018 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2018 Year 06 Month 01 Day
Last follow-up date
2019 Year 05 Month 31 Day
Date of closure to data entry
2019 Year 12 Month 31 Day
Date trial data considered complete
2019 Year 12 Month 31 Day
Date analysis concluded
2020 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2018 Year 09 Month 12 Day
Last modified on
2018 Year 09 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035363

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.