![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000016885 |
Receipt No. | R000019601 |
Scientific Title | Effects of Tapcom Combination Ophthalmic Solution Switched from Tapros 0.0015% and Timoptol XE 0.5% Solutions |
Date of disclosure of the study information | 2015/03/23 |
Last modified on | 2020/03/10 |
Basic information | ||
Public title | Effects of Tapcom Combination Ophthalmic Solution Switched from Tapros 0.0015% and Timoptol XE 0.5% Solutions | |
Acronym | Effects of Tapcom Combination Ophthalmic Solution Switched from Tapros and Timoptol XE Solutions | |
Scientific Title | Effects of Tapcom Combination Ophthalmic Solution Switched from Tapros 0.0015% and Timoptol XE 0.5% Solutions | |
Scientific Title:Acronym | Effects of Tapcom Combination Ophthalmic Solution Switched from Tapros and Timoptol XE Solutions | |
Region |
|
Condition | ||
Condition | primary open angle glaucoma, normal tension glucoma or ocular hypertension | |
Classification by specialty |
|
|
Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To investigate effects of Tapcom combination ophthalmic solution on IOP and adherence in glaucoma patients who switch treatment from Tapros ophthalmic solution 0.015% and Timoptol XE ophthalmic solution 0.5%. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | IOP reduction |
Key secondary outcomes |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Uncontrolled |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Treatment | |
Type of intervention |
|
|
Interventions/Control_1 | Switching from Tapros 0.0015% and Timoptol XE 0.5% ophthalmic solution to Tapcom combination ophthalmic solution | |
Interventions/Control_2 | ||
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 |
|
|||
Age-upper limit |
|
|||
Gender | Male and Female | |||
Key inclusion criteria | primary open angle glaucoma, normal tension glucoma or ocular hypertension
treatment with concomitant use of Tapros 0.0015%, Timoptol XE 0.5% ophthalmic solution and an anti-glaucoma drug |
|||
Key exclusion criteria | some corneal abnormality or other diseases which may interfere with accurate IOP measurement
history of corneal refractive surgery bronchial asthma or a history of the said disease bronchospasm or severe chronic obstructive pulmonary disease cardiac insufficiency, sinus bradycardia, atrioventricular block (II, or III degree) or cardiogenic shock |
|||
Target sample size | 40 |
Research contact person | |||||||
Name of lead principal investigator |
|
||||||
Organization | Kitasato University | ||||||
Division name | Department of Ophthalmology, School of Medicine | ||||||
Zip code | 252-0374 | ||||||
Address | 1-15-1 Kitasato, Minami, Sagamihara, Kanagawa, Japan | ||||||
TEL | 042-778-9735 | ||||||
nshoji@kitasato-u.ac.jp |
Public contact | |||||||
Name of contact person |
|
||||||
Organization | Kitasato University | ||||||
Division name | Department of Ophthalmology, School of Medicine | ||||||
Zip code | 252-0374 | ||||||
Address | 1-15-1 Kitasato, Minami, Sagamihara, Kanagawa, Japan | ||||||
TEL | 042-778-9735 | ||||||
Homepage URL | |||||||
nshoji@kitasato-u.ac.jp |
Sponsor | |
Institute | Kitasato University |
Institute | |
Department |
Funding Source | |
Organization | Santen Pharmaceutical Co., Ltd |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | The Institutional Review Board of Kitasato University Hospital |
Address | 1-15-1 Kitasato, Minami, Sagamihara, Kanagawa, Japan |
Tel | 042-778-7756 |
rinri@med.kitasato-u.ac.jp |
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 | 北里大学病院(神奈川県)/ Kitasato University Hospital (Kanagawa Pref.)
独立行政法人 地域医療機能推進機構 相模野病院(神奈川県)/ Japan Community Health care Organazation Sagamino Hospital (Kanagawa Pref.) とうめい厚木クリニック(神奈川県)/ Tomei Atsugi clinic (Kanagawa Pref.) 大和市立病院(神奈川県)/ Yamato Municipal Hospital (Kanagawa Pref.) 東芝林間病院(神奈川県)/ Toshiba Rinkan Hospital (Kanagawa Pref.) 神奈川歯科大学附属横浜クリニック(神奈川県)/ Kanagawa Dental University Yokohama Clinic (Kanagawa Pref.) |
Other administrative information | |||||||
Date of disclosure of the study information |
|
Related information | |
URL releasing protocol | Not applicable |
Publication of results | Published |
Result | |||||||
URL related to results and publications | https://www.scirp.org/Journal/paperinformation.aspx?paperid=96213 | ||||||
Number of participants that the trial has enrolled | 30 | ||||||
Results | Refer to published paper | ||||||
Results date posted |
|
||||||
Results Delayed | |||||||
Results Delay Reason | |||||||
Date of the first journal publication of results |
|
||||||
Baseline Characteristics | Refer to published paper | ||||||
Participant flow | Refer to published paper | ||||||
Adverse events | Refer to published paper | ||||||
Outcome measures | Refer to published paper | ||||||
Plan to share IPD | The datasets are not publicly available, but are available from the corresponding author on reasonable request. | ||||||
IPD sharing Plan description | The datasets are not publicly available, but are available from the corresponding author on reasonable request. |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
|
||||||
Date of IRB |
|
||||||
Anticipated trial start date |
|
||||||
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 |
|
||||||
Last modified on |
|
Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019601 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |