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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003214
Receipt No. R000003895
Scientific Title The study of having an inhibitory effect on occuring ocular surface disorders of Blokyleate PF ophthalmic solution 2% in a glaucomatous eye -Controlled trial with Mikelan ophthalmic solution 2%-
Date of disclosure of the study information 2010/02/19
Last modified on 2015/03/04

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Basic information
Public title The study of having an inhibitory effect on occuring ocular surface disorders of Blokyleate PF ophthalmic solution 2% in a glaucomatous eye -Controlled trial with Mikelan ophthalmic solution 2%-
Acronym The controlled trial of Blokyleate PF ophthalmic solution 2% and Mikelan ophthalmic solution 2%
Scientific Title The study of having an inhibitory effect on occuring ocular surface disorders of Blokyleate PF ophthalmic solution 2% in a glaucomatous eye -Controlled trial with Mikelan ophthalmic solution 2%-
Scientific Title:Acronym The controlled trial of Blokyleate PF ophthalmic solution 2% and Mikelan ophthalmic solution 2%
Region
Japan

Condition
Condition Primary open-angle glaucoma which is in a limited sense, normal tension glaucoma, primary angle-closure glaucoma, exfoliation glaucoma, or high-tension glaucoma
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We weigh Blokyleate PF ophthalmic solution 2% against Mikelan ophthalmic solution 2% for patients with primary open-angle glaucoma which is in a limited sense, normal tension glaucoma, primary angle-closure glaucoma, exfoliation glaucoma, or high-tension glaucoma.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase IV

Assessment
Primary outcomes The following scoring of kerato- conjunctival epithelium disorder at baseline test and 12th week of the treatment phase.
(1) Fluorescein stain score (0 to 3: 3 regions)
(2) Rosebengal stain score (0 to 3: 3 regions)
Key secondary outcomes The following scoring of a kerato- conjunctival epithelium disorder at baseline test, 4th week and 8th week of the treatment phase.
(1) Fluorescein stain score (0 to 3: 3 regions)
(2) Rosebengal stain score (0 to 3: 3 regions)

The value of an intraocular pressure at baseline test, 4th week, 8th week and 12th week / cutoff point of the treatment phase.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Period for administration (observation period):4 weeks
Mikelan ophthalmic solution:One drop of once, twice a day
Xalatan Eye Drops:One drop of once, once a day at night

Period for administration (treatment period):12 weeks ( intervention)
Blokyleat PF ophthalmic solution:One drop of once, twice a day
Xalatan Eye Drops:One drop of once, once a day at night
Interventions/Control_2 Period for administration (observation period):4 weeks
Mikelan ophthalmic solution:One drop of once, twice a day
Xalatan Eye Drops:One drop of once, once a day at night

Period for administration (treatment period):12 weeks (control)
Mikelan ophthalmic solution:One drop of once, twice a day
Xalatan Eye Drops:One drop of once, once a day at night
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 A patient who satisfies the following all selection criteria.
1) Age:20 years old or more at the time of informed consent acquisition.
2) Gender:No object.
3) Hospital patient or out patient:No object.
4) A patient who is treated with Xalatan Eye Drops and nonselective beta blocker eye drops (containing alpha beta blocker eye drops) or treated with Xalatan Eye Drops, nonselective beta blocker eye drops (containing alpha beta blocker eye drops) and carbonate dehydratase inhibitor eye drops for 3 months (12 weeks) before obtaining informed consent. However, the patient has to switch nonselective beta blocker eye drops (containing alpha beta blocker eye drops) to Mikelan ophthalmic solution 2% during the observation phase of this post marketing clinical study. For a patient using carbonate dehydratase inhibitor eye drops, you have to cease them and keep the intraocular pressure.
[Nonselective beta blocker eye drops (containing alpha beta blocker eye drops)]
Carteolol hydrochloride eyes drops (1%, 2%)
Timolol maleate eyes drops (0.25%, 0.5%)
Gelled timolol maleate eyes drops (0.25%, 0.5%)
Nipradilol Eyes Drops (0.25%)
Levobunolol hydrochloride eyes drops (0.5%)
[Carbonate dehydratase inhibitor eye drops)]
Dorzolamide hydrochloride eyes drops (0.5%, 1%)
Brinzolamid eyes drops (1%)
5) The value of evaluation-intended eye intraocular pressure at the time of the screening test and the baseline test is more than 13mmHg and under 30mmHg.
6) The visual test using Humphrey SITA-Fast or Humphrey SITA-Standard is conducted at the time of the screening test , the MD value of the evaluation-intended eye is more than -15dB . (If the visual test is carried out within 3 months before screening test, the data is acceptable.)
Key exclusion criteria At the time of informed consent acquisition and the baseline test, a patient corresponding to any of the following criterion is excluded.
1) A patient putting contact lens on the evaluation-intended eye.
2) A patient whose best-corrected visual acuity on the evaluation-intended eye is under 0.5.
3) A patient having eye disorder except for cataract and ametropia on the evaluation-intended eye. (However, the following 4)-12) are considered.)
4) A patient complicating chronic or recurrent inflammatory disorder (uveitis, scleritis, corneal herpes, and so on) on the evaluation-intended eye.
5) A patient complicating eye disorder, such as retinal degeneration, retinopathy of diabetes, allergic conjunctival disease and so on, which is judged as ineligibility for enrollment by an investigator, on the evaluation-intended eye.
6) A patient complicating infections on the evaluation-intended eye.
7) A patient having the history of glaucoma surgery on the evaluation-intended eye. (Except for the following laser surgery which is conducted before more than 3 months (12 weeks) obtaining the informed consent.) Laser iridotomy, laser trabeculoplasty and laser angleplasty.
8) A patient having the history of intraocular surgery on the evaluation-intended eye within 3 months (12 weeks)before obtaining the informed consent.
9) A patient having the history of ophthalmologic laser surgery on the evaluation-intended eye within 3 months (12 weeks) before obtaining the informed consent.
10) A patient having the history of ocular injury on the evaluation-intended eye within 3 months (12 weeks) before obtaining the informed consent.
11) A patient having the severe kerato- conjunctiva epithelium disorder (persistent epithelial defect, corneal erosion, and so on) on the evaluation-intended eye.
12) A patient interfering with applanometry on the evaluation-intended eye.
13) A patient having carteolol hydrochloride sensitivity.

Other 11 items.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Nezaki
Organization NITTEN Pharmaceutical co. ltd.
Division name Research and Development Division
Zip code
Address 76 Nishisakura-cho Minami-ku Nagoya-shi, Aichi, 457-0039
TEL 052-822-5809
Email

Public contact
Name of contact person
1st name
Middle name
Last name Akira Nezaki
Organization NITTEN Pharmaceutical co. ltd.
Division name Research and Development Division
Zip code
Address 76 Nishisakura-cho Minami-ku Nagoya-shi, Aichi, 457-0039
TEL 052-822-5809
Homepage URL
Email

Sponsor
Institute NITTEN Pharmaceutical co. ltd.
Institute
Department

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
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 東京大学医学部附属病院(東京都)、山口大学医学部附属病院(山口県)、北海道大学病院(北海道)、東北大学病院(宮城県)、筑波大学附属病院(茨城県)、自治医科大学附属病院(栃木県)、東京医科歯科大学医学部附属病院(東京都)、東京医科大学病院(東京都)、東京女子医科大学病院(東京都)、新潟大学医歯学総合病院(新潟県)、岐阜大学医学部附属病院(岐阜県)、金沢大学附属病院(石川県)、京都府立医科大学附属病院(京都府)、大阪大学医学部附属病院(大阪府)、鳥取大学医学部附属病院(鳥取県)、医療法人仁友会南松山病院(愛媛県)、琉球大学大学医学部附属病院(沖縄県)、大阪厚生年金病院(大阪府)、医療法人明和会宮田眼科病院(宮崎県)、医療法人社団研英会林眼科病院(福岡県)

Other administrative information
Date of disclosure of the study information
2010 Year 02 Month 19 Day

Related information
URL releasing protocol
Publication of results 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 09 Month 05 Day
Date of IRB
Anticipated trial start date
2008 Year 10 Month 01 Day
Last follow-up date
2010 Year 06 Month 29 Day
Date of closure to data entry
2010 Year 09 Month 03 Day
Date trial data considered complete
2010 Year 11 Month 25 Day
Date analysis concluded
2011 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 02 Month 19 Day
Last modified on
2015 Year 03 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003895

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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