UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011275 |
|---|---|
| Receipt number | 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 08:42:13 |
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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
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
Public contact
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
Sponsor or person
Institute
Department of Ophthalmology, Kanazawa University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013126
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