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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011275
Receipt No. R000013126
Scientific Title Comparison of morning vs evening dosing of the latanoprost/timolol maleate fixed combination (Xalacom) on intraocular pressure control in primary open angle glaucoma. -Pilot Study -
Date of disclosure of the study information 2013/07/25
Last modified on 2015/12/24

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Basic information
Public title Comparison of morning vs evening dosing of the latanoprost/timolol maleate fixed combination (Xalacom) on intraocular pressure control in primary open angle glaucoma.
-Pilot Study -
Acronym Comparison of morning vs evening dosing of the latanoprost/timolol maleate fixed combination (Xalacom)
Scientific Title Comparison of morning vs evening dosing of the latanoprost/timolol maleate fixed combination (Xalacom) on intraocular pressure control in primary open angle glaucoma.
-Pilot Study -
Scientific Title:Acronym Comparison of morning vs evening dosing of the latanoprost/timolol maleate fixed combination (Xalacom)
Region
Japan

Condition
Condition primary open angle glaucoma
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the intraocular pressure lowering level of the morning dosing group and the evening dosing group of the latanoprost/timolol maleate fixed combination (Xalacom) three months after switching (measured within 1 hour before/after 10:00).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Intraocular pressure lowering level
Key secondary outcomes Adherence
Safety

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 latanoprost/timolol maleate fixed combination (Xalacom) applied once daily in the morning
Interventions/Control_2 latanoprost/timolol maleate fixed combination (Xalacom) applied once daily in the evening
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
75 years-old >=
Gender Male and Female
Key inclusion criteria (1) Written informed consent: Patients capable of providing written consent by themselves after full explanation of the study details using written information to patients.
(2) Patients with glaucoma inadequately controlled with combined use of prostaglandins (except for Isopropyl Unoprostone) or In patients treated with a combination agent except the Xalacom combination agent (more than one month), intraocular pressure levels are less than 21mmHg

(3) The level of visual field defect: mean deviation with Humphrey Field Analyzer is less progressive than -10 dB within 6 months before the study.
(4) Visual acuity: better than 0.7 in best corrected visual acuity.
(5) Patients aged 20 years or older who are capable of providing consent.
(6) Males and females.
Key exclusion criteria (1) Pregnant and lactating women, the women who desired of the pregnancy.
(2) Patients who have difficulty or are unable to undergo fundoscopy (severe cataract, etc.).
(3) Patients with active external ocular diseases, ocular inflammation or infection.
(4) Patients with myopia of at least 9.0D spherical equivalent and more than hyperopia 9.0D spherical equivalent
(5) Patients with anisometropia more than 3D spherical equivalent
(6)Patients with any corneal abnormality or other condition preventing reliable applanation tonometry.
(7) Patients with history of refractive surgery, glaucoma surgery (SLT, trabeculotomy, trabeculectomy etc), vitreous surgery or retinal detachment surgery.
(8) Patients with history of surgery for cataract within 3 months before the study.
(9)Patients expected to require operation for an eye disease during the study period.
(10)Patients with serious renal impairment (nephrotic syndrome, acute renal failure, chronic renal failure, etc.)
(11) Patients with hepatic function disorder.
(12) Patients with bronchial asthma or its history.
(13) Patients with bronchospasm or serious chronic obstructive pulmonary disease.
(14) Patients with cardiac failure, sinus bradycardia, atrioventricular block (second and third degrees), or cardiogenic shock.
(15) Patients with right cardiac failure due to pulmonary hypertension.
(16) Patients with congestive cardiac failure.
(17) Patients with diabetic ketoacidosis and/or metabolic acidosis.
(18)Patients with poorly controlled diabetes mellitus.
(19)Patients with a anamnestic history of hypersensitivity to any ingredients
of the investigational product.
(20) Patients who has received administration of the adrenocortical steroid agent (except for local skin administration other than around eyes).
(21) Patients whom doctor judged to be ineligible for this study.
Target sample size 40

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Kazuhisa Sugiyama
Organization Kanazawa University
Division name Department of Ophthalmology
Zip code
Address 13-1 Takara-machi, Kanazawa, Ishikawa
TEL
Email

Public contact
1st name of contact person
1st name
Middle name
Last name Sachiko Udagawa
Organization Kanazawa University
Division name Department of Ophthalmology
Zip code
Address 13-1 Takara-machi, Kanazawa, Ishikawa
TEL 076-265-2403
Homepage URL
Email

Sponsor
Institute Department of Ophthalmology, Kanazawa University
Institute
Department

Funding Source
Organization Pfizer Inc
Organization
Division
Category of Funding Organization Profit organization
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 金沢大学附属病院(石川県)

Other administrative information
Date of disclosure of the study information
2013 Year 07 Month 25 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
2011 Year 07 Month 21 Day
Date of IRB
Anticipated trial start date
2011 Year 10 Month 26 Day
Last follow-up date
2014 Year 12 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 07 Month 25 Day
Last modified on
2015 Year 12 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013126

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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