UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026231 |
|---|---|
| Receipt number | R000030131 |
| Scientific Title | Efficacy of IOP reduction and safety of Mikeluna combination ophthalmic solution switched from Xalacom combination ophthalmic solution. |
| Date of disclosure of the study information | 2017/02/20 |
| Last modified on | 2024/08/27 10:01:22 |
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Basic information
Public title
Efficacy of IOP reduction and safety of Mikeluna combination ophthalmic solution switched from Xalacom combination ophthalmic solution.
Acronym
Efficacy of IOP reduction and safety of Mikeluna combination ophthalmic solution switched from Xalacom combination ophthalmic solution
Scientific Title
Efficacy of IOP reduction and safety of Mikeluna combination ophthalmic solution switched from Xalacom combination ophthalmic solution.
Scientific Title:Acronym
Efficacy of IOP reduction and safety of Mikeluna combination ophthalmic solution switched from Xalacom combination ophthalmic solution
Region
| Japan |
Condition
Condition
glaucoma or ocular hypertension
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate efficacy of IOP reduction and safety of Mikeluna combination ophthalmic solution switched from Xalacom combination ophthalmic solution.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
IOP reduction
Adverse event
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
| Medicine |
Interventions/Control_1
Switching from Xalacom combination ophthalmic solution to Mikeluna 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
glaucoma or ocular hypertension
good adherence before the study initiation
Key exclusion criteria
some corneal abnormality or other diseases which may interfere with accurate IOP measurement
history of glaucoma surgery
contraindicated to Beta blockers
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Inoue |
Organization
Inouye Eye Hospital
Division name
Medical office
Zip code
101-0062
Address
4-3 Kanda Surugadai, Chiyoda-Tokyo, Japan
TEL
03-3295-0911
study@inouye-eye.or.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Inoue |
Organization
Inouye Eye Hospital
Division name
Medical office
Zip code
101-0062
Address
4-3 Kanda Surugadai, Chiyoda-Tokyo, Japan
TEL
03-3295-0911
Homepage URL
study@inouye-eye.or.jp
Sponsor or person
Institute
Inouye Eye Hospital
Institute
Department
Personal name
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
Inouye Eye Hospital ethics committee
Address
4-3 Kanda Surugadai, Chiyoda-Tokyo, Japan
Tel
03-3295-0911
academy@inouye-eye.or.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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 20 | Day |
Related information
URL releasing protocol
Not disclosed
Publication of results
Unpublished
Result
URL related to results and publications
DOI: 10.1097/IJG.0000000000001091
Number of participants that the trial has enrolled
43
Results
Switching from concomitant latanoprost and CH to LCFC led to similar IOP control with good safety and patient acceptance, at least in the short term.
Results date posted
| 2024 | Year | 08 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2018 | Year | 12 | Month | 31 | Day |
Baseline Characteristics
A total of 43 patients (43 eyes) who were using latanoprost (once daily in the evening) and CH (once daily in the morning) concomitantly were switched to LCFC (once daily in the morning) with no washout interval.
Participant flow
The primary efficacy endpoint was change in intraocular pressure (IOP) between baseline (before switching) and 1 and 3 months after switching. Systemic blood pressure and pulse rate, corneal epithelial defects, and tear film break-up time (TBUT) were also compared before and 1 and 3 months after switching. A questionnaire was administered 1 month after switching to investigate ocular comfort and treatment preferences. Adverse reactions and dropouts were recorded.
Adverse events
One patient each (9.3%) discontinued treatment because of foreign body sensation, blepharitis, increased IOP, or loss to follow-up.
Outcome measures
Intraocular pressure, blood pressure, pulse rate, occurrence of other side effects and patient questionnaires were used to evaluate the intraocular pressure-lowering effect, safety and feel of use.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 01 | Month | 06 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 07 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 11 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 20 | Day |
Last modified on
| 2024 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030131
