UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013943 |
|---|---|
| Receipt number | R000014740 |
| Scientific Title | Effectiveness of Olopatadine HCl Ophthalmic Solution, 0.1% Compared to Epinastine HCl Ophthalmic Solution, 0.05% in the Treatment of Allergic Conjunctivitis to Japanese Cedar Pollen |
| Date of disclosure of the study information | 2014/05/13 |
| Last modified on | 2014/12/15 09:25:33 |
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Basic information
Public title
Effectiveness of Olopatadine HCl Ophthalmic Solution, 0.1% Compared to Epinastine HCl Ophthalmic Solution, 0.05% in the Treatment of Allergic Conjunctivitis to Japanese Cedar Pollen
Acronym
Effectiveness of Olopatadine HCl Ophthalmic Solution, 0.1% Compared to Epinastine HCl Ophthalmic Solution, 0.05% in the Treatment of Allergic Conjunctivitis to Japanese Cedar Pollen
Scientific Title
Effectiveness of Olopatadine HCl Ophthalmic Solution, 0.1% Compared to Epinastine HCl Ophthalmic Solution, 0.05% in the Treatment of Allergic Conjunctivitis to Japanese Cedar Pollen
Scientific Title:Acronym
Effectiveness of Olopatadine HCl Ophthalmic Solution, 0.1% Compared to Epinastine HCl Ophthalmic Solution, 0.05% in the Treatment of Allergic Conjunctivitis to Japanese Cedar Pollen
Region
| Japan |
Condition
Condition
Allergic Conunctivitis
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness and safety of Olopatadine HCl ophthalmic solution, 0.1% versus Epinastine HCl ophthalmic solution, 0.05% in a population of healthy, adult Japanese patients (20 years of age or older) with a history of allergic conjunctivitis to Japanese Cedar Pollen.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase IV
Assessment
Primary outcomes
Ocular itching will be evaluated by asking patients to provide a numerical rating of ocular itching for each eye at 7 minutes post allergen challenge at Visit 3. Ratings are made on a scale of 0 to 4, allowing half unit increments.
Key secondary outcomes
Conjunctival hyperemia evaluated by the investigator based on biomicroscopy for each eye at 20 minutes post allergen challenge at Visit 3.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
A group:
Left eye: Olopatadine HCl ophthalmic solution 0.1%
Right eye: Epinastine HCl ophthalmic solution, 0.05%
Interventions/Control_2
B group:
Left eye: Epinastine HCl ophthalmic solution, 0.05%
Right eye: Olopatadine HCl ophthalmic solution 0.1%
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
Patients MUST:
1. be male or female, at least 20 years of age;
2. be Japanese and living in Japan;
3. have the ability to follow study instructions and be likely to complete all required visits;
4. have a history of allergic conjunctivitis and have a positive skin test reaction to Japanese Cedar allergen at Visit 1;
5. have a positive bilateral CAC reaction (>2 itching and >2 hyperemia in the conjunctival vessel bed) within 10 minutes of instillation of the last titration of allergen at Visit 1;
6. have a positive bilateral CAC reaction ( >2 itching at the 5-minute timepoint and for at least one of the 7- or 15- minute timepoints, and >2 hyperemia in the conjunctival vessel bed for at least 2 of the 3 timepoints) at Visit 2;
7. be able and willing to avoid all disallowed medications for the appropriate washout periods and during the study (see exclusion 10);
8. be able to discontinue wearing any contact lenses during the study period, starting at least 5 days prior to Visit 1;
9. for females of childbearing potential, be using a reliable means of contraception;
10. provide written informed consent and documentation in accordance with the relevant country and local privacy requirements (where applicable) prior to participation into the study.
Key exclusion criteria
1.have a history of allergic hypersensitivity or known hypersensitivity to any compound or chemical class related to the drug being studied or its excipients used in this trial 2. have the presence of any ocular condition that, could affect the patients safety or study parameters 3. have a known history of vernal keratoconjunctivitis and/or atopic keratoconjunctivitis; 4. have had ocular surgical intervention within 3 months prior to Visit 1 and/or a history of refractive surgery within 6 months prior to Visit 1;5. have any presence of active ocular infection or preauricular lymphadenopathy, or positive history of an ocular herpetic infection at any time prior to Visit 3; 6. have any uncontrolled systemic disease; 7. have a history of status asthmaticus, a known history of persistent moderate or severe asthma, or a known history of moderate to severe allergic asthmatic reactions to study allergen(s);8. manifest signs or symptoms of clinically active allergic conjunctivitis in either eye; 9. be a female who is currently pregnant, nursing, or planning a pregnancy; 10. use any of the disallowed medications during the study period; aspirin containing products: discontinue 72 hours; H1-antagonist antihistamines and all other anti-allergy therapies : discontinue 72 hours ; all other topical ophthalmic preparations other than study drops : discontinue 72 hours; corticosteroids or mast cell stabalizers: discontinue 14 days; depot corticosteroids: discontinue 6 months 11. have a planned surgery during the trial period or within 30 days after completion; 12. have current enrollment in an investigational drug or device study or administration of investigational drug in such a study within 30 days of entry into this study; 13.have a condition or be in a situation in the investigators opinion that may put the patient at significant risk,may confound the study results, or may interfere significantly with the patients participation in the study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshinori Yamada |
Organization
Kitasato Institute Hospital
Division name
Biomedical Research Center
Zip code
Address
5-9-1 Sirogane, Minato-ku, Tokyo Japan
TEL
03-3444-6161
yamada-y@insti.kitasato-uac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sakaguchi Hironari |
Organization
Alcon Japan Ltd.
Division name
PhaseIV Development Medical Affairs
Zip code
Address
2-17-7 Akasaka, Minato-ku, Tokyo Japan
TEL
03-3588-4515
Homepage URL
Hironari.Sakaguchi@alcon.com
Sponsor or person
Institute
Alcon Japan Ltd.
Institute
Department
Personal name
Funding Source
Organization
Alcon Japan 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
北里大学北里研究所病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://link.springer.com/article/10.1007/s12325-014-0156-2
Number of participants that the trial has enrolled
Results
In conclusion, the results of this study suggest that olopatadine 0.1% is more effective than epinastine 0.05% at reducing the symptoms of Japanese cedar pollen-induced allergic conjunctivitis in CAC tests, a short-term efficacy evaluation system. Prospective
randomized controlled trials in real-life
settings are needed to confirm these results and the efficacy and safety of longer term administration of olopatadine.
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
| 2013 | Year | 12 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 19 | Day |
Last follow-up date
| 2014 | Year | 01 | Month | 26 | Day |
Date of closure to data entry
| 2014 | Year | 02 | Month | 14 | Day |
Date trial data considered complete
| 2014 | Year | 02 | Month | 14 | Day |
Date analysis concluded
| 2014 | Year | 03 | Month | 28 | Day |
Other
Other related information
There were no adverse events during the study.
Furthermore, there were no abnormal findings in slit lamp biomicroscopy, undilated fundoscopy, or physical examination at any visit. There were no significant changes in visualacuity or vital signs between Visits 1 and 3.
None of the subjects withdrew from the study because of adverse events.
Management information
Registered date
| 2014 | Year | 05 | Month | 13 | Day |
Last modified on
| 2014 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014740
