UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040896 |
|---|---|
| Receipt number | R000046674 |
| Scientific Title | The prospective observational study for the efficacy and safety of patients using Ailamide combination ophthalmic suspension with concomitant prostaglandin analogs or prostaglandin analogs / b-blocker combination drug |
| Date of disclosure of the study information | 2020/06/26 |
| Last modified on | 2023/12/29 20:16:31 |
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Basic information
Public title
The investigation of efficacy and safety of Ailamide eye drops
Acronym
The investigation of efficacy and safety of Ailamide eye drops
Scientific Title
The prospective observational study for the efficacy and safety of patients using Ailamide combination ophthalmic suspension with concomitant prostaglandin analogs or prostaglandin analogs / b-blocker combination drug
Scientific Title:Acronym
Study for the efficacy and safety of patients using Ailamide with concomitant prostaglandin analogs or prostaglandin analogs / b-blocker combination drug
Region
| Japan |
Condition
Condition
Primary open angle glaucoma
Ocular hypertension
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the efficacy and safety of patients using Ailamide combination ophthalmic suspension with concomitant prostaglandin analogs or prostaglandin analogs / b-blocker combination drug
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
IOP change from baseline at 12 weeks of additional administration of Ailamide
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with primary open-angle glaucoma (POAG) or ocular hypertension
2. Written informed consent
3. Male or female outpatient, 20 years of age or older
4. Patients treated with the same PG analogs or PG/b combination for 90 days or longer
5. Baseline IOP >= 13 mmHg
6. Corneal thickness: 450-580 micro meter
7. Required Ailamide administration for further IOP-lowering treatment
Key exclusion criteria
1. Use of other IOP lowering drug or corticosteroid within past 90 days
2. History of surgical treatment for glaucoma
3. History of intraocular surgery within past 90 days
4. Treatment of a triamcinolone acetonide within past 180 days
5. Presence of any active retinal disease which may progress
6. Presence of any active ocular disease other than POAG or ocular hypertension
7. Presence of a serious systemic disease
8. Presence of corneal abnormality which is considered to preclude accurate measurement of IOP by Goldmann applanation tonometer
9. History of corneal transplantation or keratorefractive surgery
10. Decided to be inappropriate for this study by a physician in charge accurate measurement of IOP by Goldmann applanation tonometer
9. History of corneal transplantation or keratorefractive surgery
10. Decided to be inappropriate for this study by a physician in charge
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Aihara |
| Middle name | |
| Last name | Makoto |
Organization
The University of Tokyo
Division name
Department of ophthalmology
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo 113-8655 Japan
TEL
03-5800-6415
aihara-tky@umin.net
Public contact
Name of contact person
| 1st name | Aihara |
| Middle name | |
| Last name | Makoto |
Organization
The University of Tokyo
Division name
Department of ophthalmology
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo 113-8655 Japan
TEL
03-5800-6415
Homepage URL
aihara-tky@umin.net
Sponsor or person
Institute
Department of Ophthalmology, The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Senju Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hara Eye Hospital
Omiya hamada Eye Clinic
Yotsuya Shirato Ophthalmology Clinic
Eye Rose Clinic
Yoshikawa Eye Clinic
Ohkubo Eye Clinic
Muramatsu Clinic
Grace Eye Clinic
Minami-Matsuyama Hospital
Asato Eye Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinagawa eastone midical clinic
Address
2-16-1, Minatominami Minato-ku, Tokyo
Tel
03-6718-2898
noriko-murayama@iromgroup.co.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
原眼科病院（栃木県）
大宮はまだ眼科（埼玉県）
四谷しらと眼科（東京都）
アイ・ローズクリニック（東京都）
吉川眼科クリニック（東京都）
おおくぼ眼科クリニック（石川県）
むらまつ眼科医院（静岡県）
グレース眼科クリニック（岡山県）
南松山病院 眼科（愛媛県）
安里眼科おもろまち駅前（沖縄県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
101
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
| 2020 | Year | 06 | Month | 02 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 02 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 25 | Day |
Last follow-up date
| 2021 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The purpose of this study is to verify the efficacy and safety of patients using Ailamide combination ophthalmic suspension with concomitant prostaglandin analogs or prostaglandin analogs / b-blocker combination drug. The efficacy is evaluated with IOP change from baseline at 12 weeks of additional administration of Ailamide.
Management information
Registered date
| 2020 | Year | 06 | Month | 25 | Day |
Last modified on
| 2023 | Year | 12 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046674
