UMIN-CTR Clinical Trial

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 Makoto Middle name Last name Aihara
Organization	The University of Tokyo Hospital
Division name	Department of ophthalmology
Zip code	113-8655
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 Rei Middle name Last name Sakata
Organization	The University of Tokyo Hospital
Division name	Department of ophthalmology
Zip code	113-8655
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	The University of Tokyo Hospital
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel	03-3815-5411
Email	one-stop@umin.ac.jp

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	Not applicable
Publication of results	Unpublished

Result
URL related to results and publications	Not applicable
Number of participants that the trial has enrolled	0
Results	Not applicable
Results date posted	2021 Year 02 Month 27 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Not applicable
Participant flow	Not applicable
Adverse events	Not applicable
Outcome measures	Not applicable
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 03 Month 31 Day
Date of IRB	2019 Year 08 Month 07 Day
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	2021 Year 02 Month 27 Day

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