UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000030789
Receipt No. R000035152
Scientific Title Effects of anti-allergic ophthalmic solutions on chemical mediators in tear fluid and on expression of chemical mediator receptors on conjunctival epithelial cells in patients with allergic conjunctivitis for pre-seasonal therapy
Date of disclosure of the study information 2018/01/16
Last modified on 2019/05/07 (Ver. 9)

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Basic information
Public title Effects of anti-allergic ophthalmic solutions on chemical mediators in tear fluid and on expression of chemical mediator receptors on conjunctival epithelial cells in patients with allergic conjunctivitis for pre-seasonal therapy
Acronym Effects of anti-allergic ophthalmic solutions on chemical mediators in tear fluid and on expression of chemical mediator receptors on conjunctival epithelial cells in patients with allergic conjunctivitis for pre-seasonal therapy
Scientific Title Effects of anti-allergic ophthalmic solutions on chemical mediators in tear fluid and on expression of chemical mediator receptors on conjunctival epithelial cells in patients with allergic conjunctivitis for pre-seasonal therapy
Scientific Title:Acronym Effects of anti-allergic ophthalmic solutions on chemical mediators in tear fluid and on expression of chemical mediator receptors on conjunctival epithelial cells in patients with allergic conjunctivitis for pre-seasonal therapy
Region
Japan

Condition
Condition Seasonal allergic conjunctivitis
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate changes in tear level of chemical mediators and expression of chemical mediator receptors on conjunctival epithelial cells in patient with seasonal allergic conjunctivitis for pre-seasonal therapy with epinastine hydrochloride ophthalmic solution
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change in values of the following After 4weeks and 12weeks therapy
-Expression levels of chemical mediator receptor mRNA on conjunctival epithelial cells
-Levels of chemical mediator in tears
Key secondary outcomes Change in values of the following After 4weeks and 12weeks therapy
-Subjective symptom scores
-Objective finding scores
Adverse event

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Epinastine hydrochloride ophthalmic solution, apply 1 drop a time, 4 times daily, for 12 weeks
Interventions/Control_2 Artificial tear, apply 2-3 drops a time, 5-6 times daily, for first 4 weeks and epinastine hydrochloride ophthalmic solution, apply 1 drop a time, 4 times daily, for following 8 weeks
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 Patient diagnosed with seasonal allergic conjunctivitis in the past
Positive result for cedar pollen antigen in an antigen-specific IgE examination in serum
Key exclusion criteria Patient under immunotherapy (including hyposensitization therapy and allassotherapy)
Has history of allergy to the ingredients of the study drug and clinical reagents
Patient who the investigator considers ineligible for enrolment
Target sample size 80

Research contact person
Last name of lead principal investigator
1st name Masayo
Middle name
Last name Hashimoto
Organization Santen Pharmaceutical Co., Ltd.
Division name Japan Medical Affairs Group, Development Management Department, Japan Business
Zip code 530-8552
Address 4-20, Ofukacho, Kita-ku, Osaka
TEL 06-4802-9337
Email clinical@santen.co.jp

Public contact
1st name of contact person
1st name Yoshihiro
Middle name
Last name Sugio
Organization Santen Pharmaceutical Co., Ltd.
Division name Japan Medical Affairs Group, Development Management Department, Japan Business
Zip code 530-8552
Address 4-20, Ofukacho, Kita-ku, Osaka
TEL 06-4802-9604
Homepage URL
Email clinical@santen.co.jp

Sponsor
Institute Santen Pharmaceutical Co., Ltd.
Institute
Department

Funding Source
Organization Santen Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Osaka University Hospital IRB
Address 2-15 Yamadaoka, Suita, Osaka
Tel 06-6210-8296
Email rinri@hp-crc.med.osaka-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

Other administrative information
Date of disclosure of the study information
2018 Year 01 Month 16 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 69
Results 
69 cases (Epinastine Intervention Group; 35 cases, Switch from Artificial Tears to Epinastine Intervention Group; 34 cases) were enrolled.
As for both groups, expression levels of chemical mediator receptor mRNA on conjunctival epithelial cells were significantly increased at week 12 from the baseline (week 0).
As for both groups, levels of chemical mediation in tears were not changed significantly.
Through the study period, there were no side effects for both groups.
Results date posted
2019 Year 05 Month 07 Day
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
2017 Year 10 Month 31 Day
Date of IRB
2018 Year 01 Month 10 Day
Anticipated trial start date
2018 Year 02 Month 01 Day
Last follow-up date
2018 Year 05 Month 09 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 01 Month 12 Day
Last modified on
2019 Year 05 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035152