UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013073 |
|---|---|
| Receipt number | R000015244 |
| Scientific Title | Evaluation of the efficacy and safety of anti-allergic ophthalmic solution for the treatment of allergic conjunctivitis. |
| Date of disclosure of the study information | 2014/02/05 |
| Last modified on | 2015/04/27 18:29:07 |
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Basic information
Public title
Evaluation of the efficacy and safety of anti-allergic ophthalmic solution for the treatment of allergic conjunctivitis.
Acronym
Evaluation of the efficacy and safety of anti-allergic ophthalmic solution for the treatment of allergic conjunctivitis.
Scientific Title
Evaluation of the efficacy and safety of anti-allergic ophthalmic solution for the treatment of allergic conjunctivitis.
Scientific Title:Acronym
Evaluation of the efficacy and safety of anti-allergic ophthalmic solution for the treatment of allergic conjunctivitis.
Region
| Japan |
Condition
Condition
Allergic conjunctivitis
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To make a comparative investigation of the efficacy and safety of anti-allergic ophthalmic solution for the treatment of allergic conjunctivitis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1: Change in scores of subjective symptoms (JACQLQ)
2: Changes in scores of objective symptoms (JACQLQ)
Key secondary outcomes
1: Frequency in use of steroid eyedrops.
2: Patient diary of allergic symptoms.
3: Evaluation of the corneal safety.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Epinastine hydrochloride ophthalmic solution
Interventions/Control_2
Olopatadine hydrochloride ophthalmic solution
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1: Patients whose both eyes are diagnosed as allergic conjunctivitis.
2: Patients who provided written informed consent for participating in this study.
Key exclusion criteria
1: Patients given immunotherapy.
2: Patients with surgical history in the internal eye (including laser therapy) within 3 months prior to enrollment.
3: Patients with allergy to drugs (including fluorescein) to be used during the research.
4: Patients taking medicines which affects the efficacy of study drug (including steroid, anti-allergic drugs and immunosuppressive drugs) during the research (patients can use drugs except for steroid and immunosuppressive drugs unless amount of drug is changed during the research).
5: Pregnant women, women of child-bearing potential or lactating women.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takanori Mizoguchi |
Organization
Mizoguchi Eye Clinic
Division name
Ophthalmology
Zip code
Address
6-13 Tawara-machi Sasebo Nagasaki Japan
TEL
0956-22-5681
t-mizo@siren.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takanori Mizoguchi |
Organization
Mizoguchi Eye Clinic
Division name
Ophthalmology
Zip code
Address
6-13 Tawara-machi Sasebo Nagasaki Japan
TEL
0956-22-5681
Homepage URL
t-mizo@siren.ocn.ne.jp
Sponsor or person
Institute
Mizoguchi Eye Clinic
Institute
Department
Personal name
Funding Source
Organization
Santen Pharmacceut
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Ozaki Eye Clinic
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
溝口眼科（長崎県）、尾崎眼科（宮崎県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 02 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2014 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 02 | Month | 05 | Day |
Last modified on
| 2015 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015244
