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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name