UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016310 |
|---|---|
| Receipt number | R000018933 |
| Scientific Title | Clinical efficacy of epinastine hydrochloride ophthalmic solution for allergic conjunctivitis |
| Date of disclosure of the study information | 2015/02/01 |
| Last modified on | 2017/08/18 16:13:40 |
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Basic information
Public title
Clinical efficacy of epinastine hydrochloride ophthalmic solution for allergic conjunctivitis
Acronym
Clinical efficacy of epinastine hydrochloride ophthalmic solution for allergic conjunctivitis
Scientific Title
Clinical efficacy of epinastine hydrochloride ophthalmic solution for allergic conjunctivitis
Scientific Title:Acronym
Clinical efficacy of epinastine hydrochloride ophthalmic solution for allergic conjunctivitis
Region
| Japan |
Condition
Condition
Allergic conjunctivitis
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate clinical efficacy of epinastine hydrochloride ophthalmic solution in the patients wearing contact lenses with allergic conjunctivitis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in scores of subjective symptoms
Change in scores of objective findings
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
Epinastine hydrochloride ophthalmic solution, apply 1 drop a time, 4 times daily, for 8 weeks
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients who has a positive result of type I allergy test by immuno-cap rapid
2)The planned patient who wears the contact lenses of the same product during a study
Key exclusion criteria
1)The patient at the start of the test, it is determined that the continuously during the test period should not wear contact lenses
2)Females who are or may be pregnant, or lactating
3)Patients with a history of hypersensitivity to study drug or test material
4)Patient who the investigator considers ineligible for enrolment
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Kamezawa |
Organization
Kamezawa EYE CLINIC
Division name
Kamezawa EYE CLINIC
Zip code
Address
Clinic Building 3 floor, 3-8-3 Bessho, Minami-ku, Yokohama
TEL
045-731-1113
kamezawa-ganka@pearl.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Kamezawa |
Organization
Kamezawa EYE CLINIC
Division name
Kamezawa EYE CLINIC
Zip code
Address
Clinic Building 3 floor, 3-8-3 Bessho, Minami-ku, Yokohama
TEL
045-731-1113
Homepage URL
kamezawa-ganka@pearl.ocn.ne.jp
Sponsor or person
Institute
Kamezawa EYE CLINIC
Institute
Department
Personal name
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
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 01 | 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
50 patients with allergic conjunctivitis wearing CL were instilled for 8 weeks with BAK-free epinastine hydrochloride ophthalmic solution, and clinical efficacy and safety were examined.
Itchy eye, conjunctival hyperemia and staining score of kerato and conjunctival membrane were significantly improved by ocular instillation on CL wearing, which results were similar to the previous reports. Ocular instillation on CL wearing highly satisfied the patients with allergic conjunctivitis, which resulted in the CL wearing time extended to the same level as before the morbidity.Furthermore, eye drop instillation on CL wearing didn't have harmful effects on CL fitting, there were no adverse events such as corneal and conjunctival epithelial disorder, which suggested no concern in safety.
From the above results, it can be expected that ocular instillation on CL wearing with epinastine hydrochloride ophthalmic solution can be a treatment for improving the symptoms and clinical findings of allergic conjunctivitis without impairing safety and increasing patient satisfaction.
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
| 2014 | Year | 12 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 01 | Day |
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
| 2015 | Year | 01 | Month | 23 | Day |
Last modified on
| 2017 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018933
