UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034108 |
|---|---|
| Receipt number | 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 | 2021/02/27 11:12:20 |
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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
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
reisakata-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035363
