UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001477 |
|---|---|
| Receipt number | R000001792 |
| Scientific Title | effect of latanoprost and travoprost on keratoconjunctiva l tissue |
| Date of disclosure of the study information | 2008/11/03 |
| Last modified on | 2011/05/03 12:41:29 |
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Basic information
Public title
effect of latanoprost and travoprost on keratoconjunctiva l tissue
Acronym
EXTRAKT study
Scientific Title
effect of latanoprost and travoprost on keratoconjunctiva l tissue
Scientific Title:Acronym
EXTRAKT study
Region
| Japan |
Condition
Condition
glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to investigate the effect of glaucoma eye drops including different preservatives on keratoconjunctival tissue
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the damage of corneal and conjunctival epithelium, and conjunctival hyperemia at 1 and 3 months after application of 2 kinds of IOP-lowering eye drops including a different preservative in each solution
Key secondary outcomes
the change of intraocular pressure at 1 and 3 months after application of 2 kinds of IOP-lowering eye drops including a different preservative in each solution
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
latanoprost 0.005% including benzalconium chloride preservative
3 months treatment once daily
Interventions/Control_2
travoprost 0.004% including SofZia preservative
3 months treatment once daily
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.POAG or OH using latanoprost 0.005% eye drops only over 3 months
2. not applicable for IOP level
3. not wearing contact lenses
4. not applicable for the presence of the ocular surface diseases in case the treatment was not needed
Key exclusion criteria
1. the eyes with chronic or recurrent uveitis, scleritis, corneal herpes infection
2. the eyes with the history of trauma, intraocular surgery, or Laser surgery within 6 months
3. the eyes with difficulty for the measurement of IOP with the applanation tonometer
4. the subjects with the allergy for PG-analogues or benzalconium chloride
5. the subjects using the eyedrops excluding those in this study
6. the subjects treated with oral carbonic anhydrase inhibitor
7. the subject with Sjogren syndrome
8. the subjects who can not drop periodically
9. the subjects with the advanced glaucoma or the terminal stage of glaucoma
10. the subjects with the severe ocular complications
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | makoto aihara |
Organization
university of Tokyo
Division name
Ophthalmology
Zip code
Address
7-3-1 Hongo Bunkyo Tokyo, Japan
TEL
03-3815-5411
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | makoto aihara |
Organization
University of Tokyo Hospital
Division name
ophthalmology
Zip code
Address
TEL
03-5800-8906
Homepage URL
Sponsor or person
Institute
public health research foundation
Institute
Department
Personal name
Funding Source
Organization
public health research foundation
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
| 2008 | Year | 11 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2008 | Year | 08 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
| 2009 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 11 | Month | 03 | Day |
Last modified on
| 2011 | Year | 05 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001792
