AGN-229666 Ophthalmic Solution in Japanese Patients With Allergic Conjunctivitis

NCT ID: NCT02161146

Last Updated: 2019-04-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-04

Study Completion Date

2014-12-20

Brief Summary

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This study will evaluate the safety and efficacy of AGN-229666 for the prevention of allergen-mediated conjunctivitis.

Detailed Description

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Conditions

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Conjunctivitis, Allergic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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AGN-229666

One drop of AGN-229666 in each eye on Days 1 and 15.

Group Type EXPERIMENTAL

AGN-229666

Intervention Type DRUG

One drop of AGN-229666 in the eye on Days 1 and 15.

Vehicle

One drop of Vehicle to AGN-229666 in each eye on Days 1 and 15.

Group Type PLACEBO_COMPARATOR

Vehicle to AGN-229666

Intervention Type DRUG

One drop of Vehicle to AGN-229666 in the eye on Days 1 and 15.

Olopatadine

One drop of olopatadine in each eye on Days 1 and 15.

Group Type ACTIVE_COMPARATOR

Olopatadine

Intervention Type DRUG

One drop of olopatadine in the eye on Days 1 and 15.

AGN-229666/Olopatadine

One drop of AGN-229666 in one eye and one drop of olopatadine in the other eye on Days 1 and 15.

Group Type OTHER

AGN-229666

Intervention Type DRUG

One drop of AGN-229666 in the eye on Days 1 and 15.

Olopatadine

Intervention Type DRUG

One drop of olopatadine in the eye on Days 1 and 15.

AGN-229666/Vehicle

One drop of AGN-229666 in one eye and one drop of Vehicle to AGN-229666 in the other eye on Days 1 and 15.

Group Type OTHER

AGN-229666

Intervention Type DRUG

One drop of AGN-229666 in the eye on Days 1 and 15.

Vehicle to AGN-229666

Intervention Type DRUG

One drop of Vehicle to AGN-229666 in the eye on Days 1 and 15.

Interventions

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AGN-229666

One drop of AGN-229666 in the eye on Days 1 and 15.

Intervention Type DRUG

Vehicle to AGN-229666

One drop of Vehicle to AGN-229666 in the eye on Days 1 and 15.

Intervention Type DRUG

Olopatadine

One drop of olopatadine in the eye on Days 1 and 15.

Intervention Type DRUG

Other Intervention Names

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PatanolĀ®

Eligibility Criteria

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Inclusion Criteria

-Japanese patients living in Japan with a history of allergic conjunctivitis.

Exclusion Criteria

* Presence of active eye infection (bacterial, viral, or fungal)
* History of an eye herpetic infection.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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Tokyo, , Japan

Site Status

Countries

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Japan

References

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Nakatani H, Gomes P, Bradford R, Guo Q, Safyan E, Hollander DA. Alcaftadine 0.25% versus Olopatadine 0.1% in Preventing Cedar Pollen Allergic Conjunctivitis in Japan: A Randomized Study. Ocul Immunol Inflamm. 2019;27(4):622-631. doi: 10.1080/09273948.2018.1432764. Epub 2018 Mar 15.

Reference Type BACKGROUND
PMID: 29543548 (View on PubMed)

Other Identifiers

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229666-006

Identifier Type: -

Identifier Source: org_study_id

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