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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004000
Receipt No. 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

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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
Email 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
Email aihara-tky@umin.net

Sponsor
Institute Department of Ophtalmology, University of Tokyo
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004792

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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