UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003810 |
|---|---|
| Receipt number | R000004589 |
| Scientific Title | Comparison of intraocular pressure lowering effects among four prostaglandin analogues: parallel administration to the bilateral eyes of normal subjects. |
| Date of disclosure of the study information | 2010/06/24 |
| Last modified on | 2024/01/07 11:08:52 |
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Basic information
Public title
Comparison of intraocular pressure lowering effects among four prostaglandin analogues: parallel administration to the bilateral eyes of normal subjects.
Acronym
Comparison of intraocular pressure lowering effects among four prostaglandin analogues: parallel administration to the bilateral eyes of normal subjects.
Scientific Title
Comparison of intraocular pressure lowering effects among four prostaglandin analogues: parallel administration to the bilateral eyes of normal subjects.
Scientific Title:Acronym
Comparison of intraocular pressure lowering effects among four prostaglandin analogues: parallel administration to the bilateral eyes of normal subjects.
Region
| Japan |
Condition
Condition
glaucoma, ocular hypertension
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of intraocular pressure lowering effects among four prostaglandin analogues: parallel administration to the bilateral eyes of same normal subjects
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
intraocular pressure lowering effects
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
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
The subjects instilled the latanoprost in the one eye and the taravoprost was instilled in the contralateral eye once a day at 9:00 p.m. for 2 weeks. The subject visited the hospital on Day 0,7 and 14 and underwent intraocular pressure measurement at 9a.m, 1p.m and 5p.m.
Interventions/Control_2
The subjects instilled the latanoprost in the one eye and the tafluprost was instilled in the contralateral eye once a day at 9:00 p.m. for 2 weeks. The subject visited the hospital on Day 0,7 and 14 and underwent intraocular pressure measurement at 9a.m, 1p.m and 5p.m.
Interventions/Control_3
The subjects instilled the latanoprost in the one eye and the bimatoprost was instilled in the contralateral eye once a day at 9:00 p.m. for 2 weeks. The subject visited the hospital on Day 0,7 and 14 and underwent intraocular pressure measurement at 9a.m, 1p.m and 5p.m.
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
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
20 years or older healthy volunteers with 18 mmHg or lower intraocular pressure in both eyes prior to the study.
Key exclusion criteria
subjects with glaucoma or ocular hypertension (including secondary and exfoliative glaucoma diagnosed before), keratitis and conjunctivitis,a 2mmHg or greater laterality in the mean intraocular pressure, and using contact lenses. Subjects taking drugs which influence the intraocular pressure and having a history of drug allergy to the prostaglandin analogues.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ichiro Kawaguchi |
Organization
Houju Memorial Hospital
Division name
Department of Ophthalmology
Zip code
Address
11-71 Midorigaoka Nomi, Ishikawa
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Houju Memorial Hospital
Division name
Department of Ophthalmology
Zip code
Address
TEL
Homepage URL
eyes-cream@hotmail.co.jp
Sponsor or person
Institute
Department of Ophthalmology, Houju Memorial Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2010 | Year | 06 | Month | 24 | 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
| 2010 | Year | 06 | Month | 18 | Day |
Date of IRB
| 2010 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2010 | Year | 06 | Month | 21 | Day |
Last follow-up date
| 2010 | Year | 08 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 06 | Month | 23 | Day |
Last modified on
| 2024 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004589
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
