UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004000 |
|---|---|
| Receipt number | R000004792 |
| Scientific Title | Effect of latanoprost and travoprost ophthalmic solution on corneal epithelium |
| Date of disclosure of the study information | 2010/08/20 |
| Last modified on | 2015/08/05 13:50:41 |
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Basic information
Public title
Effect of latanoprost and travoprost ophthalmic solution on corneal epithelium
Acronym
Effect of latanoprost and travoprost ophthalmic solution on corneal epithelium
Scientific Title
Effect of latanoprost and travoprost ophthalmic solution on corneal epithelium
Scientific Title:Acronym
Effect of latanoprost and travoprost ophthalmic solution on corneal epithelium
Region
| Japan |
Condition
Condition
glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
the effect of benzalkonium chloride (BAK)-preserved latanoprost ophthalmic solution and BAK-free travoprost on the corneal epithelium
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
the incidence of superior punctate keratitis (SPK)
Key secondary outcomes
the change of tear break up time and IOP reduction
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Benzalkonium chloride (BAK)-preserved latanoprost ophthalmic solution 0.005% once daily for 3 months into one of a subject
Interventions/Control_2
Benzalkonium chloride (BAK)-free travoprost ophthalmic solution 0.004% once daily for 3 months into contralateral eye of a subject
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.adult patients with OAG or glaucoma suspects treated latanoprost monotherapy for at least 3 months
2.at baseline, fluorescent staining score of superior punctate keratitis was over 1 in both eyes through consecutive 2 visits
3.out of consideration of IOP under the treatment
Key exclusion criteria
1) a past history of ocular inflammatory diseases, ocular surgery, or traumatic diseases less than 3 months before entry, 2) use of other topical eye drops or systemic ocular hypertensive drugs, 3) patients who wear contact lenses, or 4) under 20 years old during the study. Moreover, patients at risk of visual field progression or visual acuity worsening during the study were excluded according to the judgement of physicians in charge.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | makoto aihara |
Organization
University of Tokyo
Division name
Department of Ophthalmology
Zip code
Address
7-3-1 Hongo Bunkyo-ku, Tokyo, JAPAN
TEL
03-3815-5411
aihara-tky@umin.net
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | makoto aihara |
Organization
University of Tokyo
Division name
Department of Ophthalmology
Zip code
Address
7-3-1 Hongo Bunkyo-ku, Tokyo, JAPAN
TEL
03-3815-5411
Homepage URL
aihara-tky@umin.net
Sponsor or person
Institute
Department of Ophtalmology, University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Public Health Research Center, Japan
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
JAPAN
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 | 08 | Month | 20 | 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 | 08 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 08 | Month | 05 | Day |
Last modified on
| 2015 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004792
